Devices and methods for performing subcutaneous surgery

ABSTRACT

Devices and methods for performing subcutaneous surgery in a minimally invasive manner are provided. The methods include application of reduced air pressure in a recessed area of a handpiece placed over a section of skin and drawing the section of skin and subcutaneous tissue into the recessed area. In a subsequent step a tool is inserted through a tool conduit in the handpiece and through the skin into the subcutaneous tissue, enabling the performance of the desired surgery. Common surgical procedures include dissection and ablation. The devices and methods can be directed at the treatment of skin conditions like atrophic scars, wrinkles, or other cosmetic issues, at treatments like or promoting wound healing or preventing hyperhidrosis, or can be used for creating space for various implants.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 14/296,353, filed Jun. 4, 2014, which is a continuation of U.S.patent application Ser. No. 14/060,437, filed on Oct. 22, 2013, now U.S.Pat. No. 9,358,064, which is a continuation-in-part of co-pending U.S.patent application Ser. No. 13/712,429, filed Dec. 12, 2012, now U.S.Pat. No. 9,011,473, which is a continuation of U.S. patent applicationSer. No. 12/787,382, filed May 25, 2010, now U.S. Pat. No. 8,518,069,which claims priority from U.S. Provisional Application No. 61/232,385filed Aug. 7, 2009 and U.S. Provisional Application No. 61/286,750 filedDec. 15, 2009, all of which are incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates to surgical tools and methods forperforming corrective and cosmetic surgical procedures in thesubcutaneous tissue space.

BACKGROUND Atrophic Scars, Acne

Atrophic scars are the most ubiquitous type of scars, and arecharacterized by skin depressions caused by a loss of underlyingsupporting structure, such as collagen, fat or muscle. Various types ofatrophic scars exist, secondary to conditions like trauma, inflammationor disease. The most frequently observed types of atrophic scars arethose caused by common acne. Subcutaneous treatment of atrophic scarshas the potential of elevating the sunken depressions, provided that anadequate subdermal pocket can be created, to be filled with eitherendogenous wound healing tissue or with injected or implanted material.Key to the creation of an adequate pocket is the dissection of fibrousstrands or septae anchoring the skin in many atrophic scars to theunderlying tissue. A surgical treatment sometimes used for the treatmentof atrophic scars is Subcision®, in which a tri-beveled needle isrepeatedly inserted into the subcutaneous space to cut subcutaneoustissue, specifically the fibrous septae, releasing the skin from itsattachment to deeper structures. In a typical procedure the needle maybe inserted many times, moving in fan-shape patterns radiating from itsaccess site. This may be followed by a fan-like sweeping action, toensure full detachment of the tissue layers. This procedure makes themethod time consuming and prone to inadvertent deeper injury due to thelarge number of lancing movements with the needle. Additionally, inclinical practice, re-depression after an initially seemingly successfulprocedure is commonly observed. It is thought initially blood andextracellular fluid fill a pocket around the dissected needle tracks,that provides lift to the treated scar. When an inadequate pocket iscreated, resorption of the coagulated blood and fluids over time maycause the pocket to collapse, causing the late failure. Re-depressionmay also occur from reformation of scar tissue in response to themultiple planes of injury.

Wrinkles

Facial skin is unique because of its connections to the underlyingSuperficial Muscular Aponeurotic System (SMAS). The SMAS is a layer ofmusculature, responsible for facial expressions and is attached tofacial skin through numerous fibrous septae. As a consequence, skinregions heavily involved in facial expressions are densely attached, andwith progressing age such areas will start to show such expression linesknown as wrinkles, crow's feet and laughing lines. Two approaches arecommonly used in cosmetic surgery to improve the appearance of skinaround and over these expression lines. One relies on subdermaltightening (Plication) of the SMAS, which tightens the overlying skinthrough the attachment septae, after which the excess skin is dissected.In this case the role of the septae is beneficial. The other approachemploys fillers, like collagen or hyaluronic acid to bulk up the spacebelow the skin. This approach by itself often results in unsatisfactoryresults, because of the fixed attachment of the skin to the underlyingSMAS. In these cases, controlled severing of the fibrous septae mayallow for a more effective use of the fillers to reduce the appearanceof expression lines.

Subcutaneous Implants

Subcutaneous implants may be used for a variety of purposes. Theyinclude shape-enhancing implants used in cosmetic or reconstructivesurgery and therapeutically used implants like subcutaneous venousaccess ports, battery packs for implanted electronic devices, implanteddrug delivery devices and other implanted medical devices. Rapid andcontrollable creation of a subcutaneous pocket is a key component of theimplantation procedure for such devices.

Wound Healing

Contractile scar formation can be a serious and sometimes debilitatingside effect of wound healing. Tension within the plane of the skin atthe site of the wound is generally considered a significant factor inthe development of contractile scarring. In the presence of non-elasticfibrous septae connecting the dermis to the underlying subcutaneoustissue around a wound, tension from the suture used to close the woundmay be highly localized at the site of the wound. The skin itself tendsto be more elastic than the fibrous septae connecting it to theunderlying tissue. Consequently, severing the fibrous septae may relievethe local stress, as the tension is distributed over a wider area ofskin.

Liposuction

Cosmetic liposuction is one of the most commonly performed cosmeticsurgical procedures. While the results are generally favorable, there isa certain percentage of patients where uneven subcutaneous fatdistributions or skin irregularities are observed at the end of thehealing period. Frequently, these are caused by the presence of fibrousseptae connecting the skin to underlying subcutaneous tissue layers,and, occasionally, by the development of scar-like adhesions afterliposuction surgery. Both of these phenomena may cause a lack ofmobility which prevents the skin from assuming the desired smoothcontour lines of the treated body parts. Additionally, secondarytreatment procedures are sometimes performed, in which adipose tissue ismoved or transplanted from areas with excess fat to areas withinsufficient support for the overlying skin. The presence of scar-likeadhesions or fibrous septae connecting the skin to underlyingsubcutaneous layers may interfere with a physician's ability to removeunwanted fat, or reposition such fat at desired locations. All thesecases have in common the presence of unwanted connective tissue in asubcutaneous space. Traditional open cosmetic surgery would negate theadvantages of the minimally invasive liposuction procedure, and aminimally invasive procedure to treat the unwanted connective tissue isneeded to complement liposuction in these patients.

Hyperhidrosis

Hyperhidrosis is a condition characterized by an excessive production ofsweat by echini sweat glands, specifically in the armpits, hands andfeet. Eccrine sweat glands are mostly located in a relatively narrowtissue region underneath the dermis and are innervated by branches ofthe sympathetic nerve system. Current treatments range from the use ofprescription strength aluminium chloride (anti-persiprant) and botulininjection, to surgery, including sweat gland extraction and thoracicsympathectomy, in which a branch of the sympathetic nerve system issevered. Sweat gland extraction may be time consuming andlabor-intensive, while significant side effects of thoracicsympathectomy have been reported.

In all these cases, there is a need for a device and a method thatenable an efficient performance of subcutaneous corrective surgery,capable of creating a subcutaneous dissection plane, severing certaintarget anatomical structures and, where necessary, providing a tissuepocket for further corrective procedures.

SUMMARY OF THE INVENTION

A minimally invasive subcutaneous treatment device is disclosed. Thedevice comprises a handpiece having a perimeter elevation and a topwhich cooperatively define a recessed area with an inner side of theperimeter elevation and the top defining an apposition surface facinginto the recessed area; a conduit extending through a side of theperimeter elevation to the recessed area; a tool configured to at leastpartially extend through the conduit and into the recessed area; and aguidance track operably connected to the handpiece, wherein the guidancetrack is configured to constrain a portion of the tool in contact withthe guidance track to move along a predetermined path to cooperativelymove a distal end of the tool within the recessed area in a planesubstantially parallel to the top of the handpiece and within a regionof a predetermined shape defined by the predefined path.

In some aspects, the device further comprises an entry hole disposed onan inner side of the conduit and facing said recessed area, said entryhole defining a tool pivot point when a distal end of the tool isinserted through the conduit and into the recessed area, wherein theconduit widens outward toward an outer side of the perimeter elevationsuch that a distal end of the tool inserted through the entry hole movesin one direction when a proximal end of the tool outside the conduitmoves in an opposite direction.

In some aspects, the device may also comprise a platform operativelyconnected to the handpiece, wherein the platform includes the guidancetrack; and a guide pin operably connected to the tool, said guide pinslidably engaging the guidance track such that the tool is constrainedto move in accordance with the predetermined path. In some aspects, theplatform can be fixed with respect to the handpiece and substantiallyorthogonal to a bottom edge of the handpiece. The guidance track mayform a groove in a top of the platform, or, in some aspects, theguidance track is a contour formed from an edge of the platform. Theguidance track may include an undercut portion and the guide pin canhave an enlarged head such that the interference between the enlargehead and the undercut portion of the guidance track inhibits removal ofthe enlarged head from the guidance track while permitting the guide pinto be moved in accordance with the predetermined path.

In some aspects, the tool comprises a cutting blade and a reciprocatingmotor coupled to the cutting blade, said reciprocating motorreciprocating the cutting blade. The tool may further include a sleeve,wherein the cutting blade is at least partially slidably disposed withinthe sleeve. The tool may also include an injection device and a nozzle,wherein the nozzle is configured to discharge a fluid in a directionparallel to the top of the handpiece and configured to increase akinetic energy of the fluid when the fluid is injected by the injectiondevice through the nozzle.

In further aspects, the top of the handpiece is configured to beadjustable and configured to change the distance between an inner sideof the top of the handpiece and a bottom edge of the perimeter elevationand changes a volume of the recessed area when the top is adjusted. Insome aspects, the handpiece includes a reversible lid, and, the top ofthe handpiece being configured to be adjustable includes the reversiblelid being configured to be disconnected from the handpiece, turned over,and reconnected. In certain aspects, the top of the handpiece includes arigid upper lid and a rigid lower lid, the rigid upper lid being fixedwith respect to the perimeter elevation, the device further including aninflatable bladder disposed between the rigid upper lid and rigid lowerlid, wherein the rigid lower lid is configured to move up and down withrespect to a wall of the perimeter elevation, the rigid inner lid beingat its lowest point when the bladder is fully expanded, and being at itshighest point when the bladder is deflated. In other aspects, the top ofthe handpiece is operably connected to a perimeter wall of the perimeterelevation by a threaded engagement, the top of the handpiece beingrotatably mounted to the perimeter wall, and wherein rotation of the toprelative to the perimeter wall adjusts the volume of the recessed area.The top of the handpiece may also include an upper rim disposed betweenan upper edge of an outer wall and an upper edge of inner wall, arecessed surface disposed at a bottom edge of the inner wall, aperimeter of the recessed surface being substantially defined by abottom edge of the inner wall, and a first and second reference mark,the first reference mark being spaced a rotational distance from thesecond reference mark such that the rotational distance corresponds topredetermined vertical distance along the threaded engagement. An o-ringmay be interposed between the top of the handpiece and the perimeterwall of the handpiece.

The device may also be configured to include an elastomeric septum, theelastomeric septum being configured to be pierced by the tool and tosubstantially self-seal when the tool is removed such as tosubstantially prevent a vacuum leakage from the recessed area when avacuum is supplied to the recessed area. Other aspects may include thedevice comprising a support arm having a guide pin, the tool beingmounted to the support arm, wherein the guidance track operablyconnected to the handpiece includes the guidance track being disposed ona surface of the top of the handpiece and slidably receiving the guidepin, the guidance track facilitating movement of the pin and support armalong the predetermined path.

In a yet further aspect, the tool is an elongate RF cutting probe. Inthis aspect, the device may further include an RF generator operablyconnected to and supplying a power to the RF cutting probe, and acircuit for measuring the impedance of a tissue disposed within therecessed area, wherein the RF generator includes a feedback control onthe power supplied to the probe based on a measured impedance of thetissue such that the RF generator supplies a consistent power. Incertain aspects, a temperature means on the RF cutting probe is alsoincluded. The temperature measuring means is used to communicateinformation indicative of a temperature of the tissue to the RFgenerator, wherein the feedback control stops supplying power to the RFcutting probe when a temperature of the tissue reaches a predefinedthreshold.

Some aspects of the device may include a vacuum fitting operablyconnected to one of the top and the perimeter elevation and in fluidcommunication with the recessed area. These aspects may also include avacuum pump in fluid communication with the vacuum fitting, wherein thevacuum pump is configured to supply a suction force to the recessed areaand configured to pull a tissue snugly and securely against theapposition surface when the recessed area is placed over the tissue.

It may also be desirable is some aspects to use the device to inject afluid. In some aspects, the tool may be a needle, and the device mayfurther include a pump and a source of injectable fluids in fluidcommunication with the pump, wherein the needle is in fluidcommunication with the pump, and the needle is configured to inject theinjectable fluids into a tissue disposed in the recessed area. Incertain aspects, the needle may include a lumen, a tip for piercing adermis, and at least two injection ports in communication with thelumen, wherein the ports are linearly disposed along an outer surface ofthe needle. In some aspects, the ports may be flush with a side of theneedle. The ports may be configured to discharge a fluid in a directionsubstantially orthogonal to an axis of the needle and substantiallyparallel to the top of the handpiece. Some aspects of the foregoing mayfurther include a microprocessor having a graphical user interface,wherein the pump is configured to communicate information specifying avolume of a fluid injected into the tissue to the microprocessor. Themicroprocessor can be configured to use the graphical user interface toprompt a user to enter information specifying at least one of aconcentration of a component of the fluid and a weight of the patient,and the microprocessor can include logic for determining a maximumdosage of the fluid injected based on the weight of the patient, theconcentration of the component of the fluid, and the volume of the fluidinjected. In some aspects, the microprocessor is configured to cause thegraphical interface to display at least one warning message when thevolume of the fluid injected exceeds a predefined threshold which isless than the maximum dosage, and may also be configured to instruct thepump to terminate an injection when the volume of the fluid injectedreaches the maximum dosage. In further aspects, the graphical userinterface may be configured to enable the user to over-ride the maximumdosage such that the pump continues to inject the fluid once the maximumdosage has been reached. In yet further aspects, the microprocessor maybe configured to track an amount of elapsed time since the pumpinitiated pumping the fluid and to calculate a recommended treatment endtime using information selected from a group consisting of the volume offluid injected and the elapsed time. In certain aspects including avacuum pump, the vacuum pump may be configured to communicate with themicroprocessor and the graphical user interface to display an elapsedamount of time a vacuum was supplied to the handpiece by the vacuumpump. The vacuum pump may also be, in some aspects, configured tocommunicate with the microprocessor and the graphical user interface todisplay a vacuum pressure. It is not necessary that these aspectsregarding injection of a fluid and microprocessor control be limited adevice wherein the tool is a needle, but it may also be desirable toinclude these aspects and/or limitations in any of the aspects hereindescribed.

Also disclosed is a method of performing subcutaneous surgery, themethod comprising the steps of (1) providing a handpiece having aperimeter elevation and a top which cooperatively define a recessedarea, an inner side of the perimeter elevation and top defining a tissueapposition surface facing into the recessed area, and a conduitextending through a side of the perimeter elevation into the recessedarea; (2) positioning the handpiece over a first treatment area locatedon a dermis; (3) applying a force to the handpiece to move a portion ofthe dermis into the recessed area to substantially fill the recessedarea, such that a portion of the dermis is in contact with a substantialarea of the tissue apposition surface and a subcutaneous tissue isdisposed in the recessed area; (4) inserting a distal end of a toolthrough the conduit and through the dermis and into the subcutaneoustissue; and, (4) guiding the tool along a predetermined path of aguidance track to move a distal end of the tool in a plane parallel tothe top of the handpiece and within the recessed area, to create asurgical lesion of a predetermined shape defined by the predefined path.

In certain aspects, the method may also include moving the distal end ofthe tool in an x and y direction along the plane parallel to the top ofthe handpiece. Certain aspects may also include providing a vacuumassisted suction force to the recessed area to move the dermis into therecessed area.

The method may include adjusting a height of the top of the handpiece inrelation to an entry point of the conduit within the recessed area toadjust the volume of the recessed area and a depth of the subcutaneoustissue accessible by the tool when inserted through the conduit. In someaspects, the top includes a reversible lid, and the height is adjustedby disconnecting the reversible lid from the handpiece, turning it over,and reconnecting it to the handpiece. Some aspects of adjusting a heightof the top of the handpiece may include rotating the top of thehandpiece with respect to the perimeter elevation along a threadedengagement between the top of the handpiece and the perimeter elevationof the handpiece. In other aspects, the top of the handpiece may includea rigid upper lid and a rigid lower lid, the rigid upper lid being fixedwith respect to the perimeter elevation, wherein adjusting a height ofthe top of the handpiece includes inflating a bladder disposed betweenthe rigid upper lid and rigid lower lid to move the rigid lower lid upand down with respect to a wall of the perimeter elevation, the rigidinner lid being at its lowest point when the bladder is fully expandedand being at its highest point when the bladder is deflated.

Some aspects of the method may include the further steps of (a) removingthe distal end of the cutting device from the subcutaneous tissue; (b)positioning the handpiece over a second treatment area located on thedermis, wherein the second treatment area is proximal the firsttreatment area; (c) applying a force to the handpiece to move a portionof the second treatment area of the dermis into the recessed area tosubstantially fill the recessed area, such that a portion of the secondtreatment area of the dermis is in contact with a substantial area ofthe tissue apposition surface and a second layer of subcutaneous tissueis disposed in the recessed area; (d) inserting a distal end of a toolthrough the conduit and through the dermis and into the second layer ofsubcutaneous tissue; and (e) guiding the tool along the predeterminedpath of the guidance track to move the distal end of the tool in theplane parallel to the top of the handpiece and within the recessed area,to create a second surgical lesion of the predetermined shape defined bythe guidance track. In some aspects, the second treatment area may alsoat least partially overlap the first treatment area, and/or adjusting aheight of the top of the handpiece in relation to an entry point of theconduit within the recessed area to change the volume of the recessedarea and a depth of the subcutaneous tissue accessible by the tool.

In some aspects of the method, the tool is an elongated RF, laser,ultrasound, or thermal probe, and creating a surgical legion includesapplying one of a RF energy, laser energy, ultrasound energy and heat toablate a portion of the subcutaneous tissue. In further aspects, theportion of the subcutaneous tissue may include adipose tissue, or,include fibrous septae and creating a surgical legion includes cuttingthe fibrous septae. In some aspects, the tool is a catheter having ahigh-pressure fluid jet, and wherein the method of creating a surgicallegion includes injecting a fluid at a high pressure and parallel to thetop of the handpiece to displace a portion of the subcutaneous tissue.

Embodiments of the invention may enable the use of a variety of cutting,coagulation and hemostasis means by a physician.

Electrocautery encompasses passing electrical current through a tool toraise its temperature and using the hot tool to seal blood vessels andinduce coagulation. If the tool is equipped with a sharp edge or othercutting mechanism, cutting and coagulation may be performedsimultaneously. Because of the high level of conductive hear transfer anextensive heat-affected tissue zone may be created.

In radiofrequency electrosurgery a current is run from a surgical toolto a counter-electrode outside the patient, and the current actuallyruns through the patient instead of through the tool. Due to the highresistance at the tool-tissue interface a local heat zone develops, butbecause of the low levels of conductive heat transfer the heat zone maybe in the sub-millimeter range. By modulating the applied voltage from a“cutting” setting to a “coagulation” setting a physician may select froma range of operating modes defined by these two modalities.

These and other tools currently available in medical practice allow aphysician to select from a wide variety of treatment options and tailora treatment to specific patient needs. The functionality of embodimentsof the invention may be independent of the type of surgical toolselected by the physician. Therefore, embodiments of the invention mayenable a physician to select an optimal treatment for the patient andthe specific disease condition from the available cutting andcoagulation tools, without limitations due to the embodiment of theinvention used to implement the procedure.

In some aspects, the handpiece has perimeter elevation and a top whichcooperatively define a recessed area; and a vacuum conduit extendingthrough a side of the perimeter elevation to the recessed area. In someaspects the vacuum conduit can be connected to a vacuum device.

Also disclosed are methods for performing subcutaneous surgery in aregion underlying skin tissue having a deformity, comprising positioninga handpiece having a recessed area over a section of skin, reducing airpressure inside the recessed area to move a portion of the section ofskin and a subcutaneous tissue into the recessed area, inserting alesion creation tool through a conduit in the handpiece and through thesection of skin into the subcutaneous tissue, and creating a lesion inthe subcutaneous tissue, wherein the deformity is selected from a scar,a wrinkle, and a surface irregularity resulting from liposuction, andfollowing creation of the lesion an appearance of the deformity isimproved.

Also disclosed are methods for performing subcutaneous surgery whereincreating a lesion comprises dissecting tissue.

Also disclosed are methods for performing subcutaneous surgery whereincreating a lesion comprises ablating tissue.

Also disclosed are methods for performing subcutaneous surgery furthercomprising maintaining reduced air pressure in a recessed area of ahandpiece after creating a lesion for a period of time determined by aphysician.

Also disclosed are methods for performing subcutaneous surgery, whereinsubcutaneous tissue comprises a fibrous septum, and wherein creating alesion comprises severing the fibrous septum.

Also disclosed are methods for performing subcutaneous surgery in aregion underlying skin tissue having a scar, wherein the scar is anatrophic scar.

Also disclosed are methods for performing subcutaneous surgery in aregion underlying skin tissue having an atrophic scar, wherein theatrophic scar is an acne scar.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion is directed at improving a distribution of fatunderlying a section of skin.

Also disclosed are methods for performing subcutaneous surgery in aregion underlying skin tissue having a previously closed wound,comprising positioning a handpiece having a recessed area over a sectionof skin comprising the previously closed wound, reducing air pressureinside the recessed area to move a portion of the section of skin and asubcutaneous tissue into the recessed area, inserting a lesion creationtool through a conduit in the handpiece and through the section of skininto the subcutaneous tissue, and creating a lesion in the subcutaneoustissue, wherein following creating the lesion scar formation associatedwith healing of the wound is reduced.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion relieves local tension in tissue adjacent to apreviously closed wound.

Also disclosed are methods for performing subcutaneous surgery in aregion underlying skin tissue affected by hyperhidrosis, comprisingpositioning a handpiece having a recessed area over a section of skinaffected by hyperhidrosis, reducing air pressure inside the recessedarea to move a portion of the section of skin and a subcutaneous tissueinto the recessed area, inserting a lesion creation tool through aconduit in the handpiece and through the section of skin into thesubcutaneous tissue, and creating a lesion in the subcutaneous tissuewherein following creation of the lesion the hyperhidrosis is inhibited.

Also disclosed are methods for performing subcutaneous surgery, whereina section of skin overlies at least one sweat gland.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises dissecting the sweat gland.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises thermally ablating the sweat gland.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises chemically ablating the sweat gland.

Also disclosed are methods for performing subcutaneous surgery, whereina section of skin overlies at least one efferent nerve to a sweat gland.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises dissecting the nerve.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises thermally ablating the nerve.

Also disclosed are methods for performing subcutaneous surgery, whereincreating a lesion comprises chemically ablating the nerve.

Also disclosed are methods for performing subcutaneous surgery to createa lesion for a subcutaneous tissue pocket for introducing a substance,comprising positioning a handpiece having a recessed area over a sectionof skin, reducing air pressure inside the recessed area to move aportion of the section of skin and a subcutaneous tissue into therecessed area, inserting a lesion creation tool through a conduit in thehandpiece and through the section of skin into the subcutaneous tissue,and creating the lesion in the subcutaneous tissue.

Also disclosed are methods for performing subcutaneous surgery to createa lesion for a subcutaneous tissue pocket for introducing a substance,further comprising introducing the substance into the tissue pocket.

Also disclosed are methods for performing subcutaneous surgery, whereinthe substance comprises at least one of a medical device, a drug, abiologic and a combination product.

Also disclosed are methods for performing subcutaneous surgery, whereinthe substance comprises a non-regulated component.

Also disclosed are methods for treating a previously formed subcutaneouslesion created to sever a subcutaneous fibrous septum, the methodcomprising positioning a handpiece having a recessed area over a sectionof skin overlying the lesion, reducing the air pressure inside therecessed area to move a portion of the section of skin and asubcutaneous tissue into the recessed area, and maintaining reduced airpressure for a pre-determined period of time.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for improving an appearance of a feature in a section ofskin overlying the lesion, the method comprising positioning a handpiecehaving a recessed area over the section of skin overlying the lesion,reducing the air pressure inside the recessed area to move a portion ofthe section of skin and a subcutaneous tissue into the recessed area,and maintaining reduced air pressure for a pre-determined period oftime; wherein the appearance of the feature is improved relative to theappearance of the feature prior to maintaining the reduced air pressure.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for improving an appearance of a feature in a section ofskin overlying the lesion, wherein the feature comprises an atrophicscar.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for improving an appearance of a feature in a section ofskin overlying the lesion, wherein an atrophic scar is an acne scar.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for improving an appearance of a feature in a section ofskin overlying the lesion, wherein the feature comprises a wrinkle.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for improving an appearance of a feature in a section ofskin overlying the lesion, wherein the feature comprises a skin surfaceirregularity caused by liposuction.

Also disclosed are methods for treating a previously formed subcutaneouslesion created for reducing scar formation associated with healing of apreviously closed wound, the method comprising positioning a handpiecehaving a recessed area over a section of skin comprising the previouslyclosed wound, reducing the air pressure inside the recessed area to movea portion of the section of skin and a subcutaneous tissue into therecessed area, and maintaining reduced air pressure for a pre-determinedperiod of time; wherein the scar formation is reduced.

A method for treating a previously formed subcutaneous lesion createdfor dissecting sweat glands to treat hyperhidrosis, the methodcomprising positioning a handpiece having a recessed area over a sectionof skin overlying the lesion, reducing the air pressure inside therecessed area to move a portion of the section of skin and asubcutaneous tissue into the recessed area, and maintaining reduced airpressure for a pre-determined period of time; wherein healing of thesweat glands is inhibited.

A method for treating a previously formed subcutaneous lesion createdfor dissecting nerves innervating sweat glands to treat hyperhidrosis,the method comprising positioning a handpiece having a recessed areaover a section of skin overlying the lesion, reducing the air pressureinside the recessed area to move a portion of the section of skin and asubcutaneous tissue into the recessed area, and maintaining reduced airpressure for a pre-determined period of time; wherein healing of thenerves is inhibited.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1C depict a dissection device, including a handpieceand a cutting tool.

FIGS. 2A and 2B depict a cut-away side view and perspective view of thehandpiece used in conjunction with a cutting tool.

FIGS. 3A and 3B depicts a perspective view of the handpiece and motorcontrolled cutting mechanism.

FIG. 4 is an exploded view of the motor-controlled cutting mechanism.

FIGS. 5A and 5B depict an enlarged view of an embodiment the cuttingtool used in connection with the motor controlled cutting mechanism.

FIGS. 6A and 6B depict the handpiece used in connection with a removableguidance track.

FIG. 7 depicts a perspective view of the handpiece and motor controlledcutting mechanism used in connection with the method.

FIGS. 8A through 8C depict the operational range of the handpiece andmotor controlled cutting mechanism used in connection with an embodimentof the guidance track.

FIGS. 9A through 9C depict configuration and placement of the handpieceon a dermis of a patient and an alternate embodiment of the guidancetrack.

FIGS. 10A and 10B depict an embodiment of the guidance track, includinga syringe pump connected to needle or cannula and a source of injectablefluids.

FIGS. 11A through 11D depict an embodiment of the dissection device andcutting tool, including a guidance track positioned on the top of thedevice.

FIGS. 12A and 12B depict the handpiece with a reversible lid and anembodiment of a detachable guidance track.

FIGS. 13A and 13B depict exploded and cut-away views of the dissectionhandpiece, including an inflatable bladder for controlling cuttingdepth.

FIGS. 14A and 14B depict exploded and cut-away views of the dissectionhandpiece, including a threaded engagement for controlling cuttingdepth.

FIG. 15 depicts a microprocessor and display for use with theembodiments.

FIG. 16A depicts an embodiment of the cutting device, including an RFcutter.

FIG. 16B depicts a block diagram of system, including the handpiece andRF cutting tool.

FIG. 17 depicts an embodiment of an RF device, including an inflatablemember having an RF electrode provided on an exterior surface.

FIG. 18 depicts an embodiment of a cutting tool.

FIGS. 19A through 19C depict embodiments of the cutting tool with one ormore retractable blade members.

FIG. 20 depicts a blade support mechanism.

FIGS. 21A and 21B depict embodiments of the cutting tool.

FIGS. 22A through 22D depict another embodiment of the cutting tool.

FIGS. 23A through 23E depict a first embodiment of a mesh deploymentapplicator.

FIGS. 24A through 24F depict a second embodiment of a mesh deploymentapplicator, including a deployment shaft and keeper rod.

FIG. 25 depicts a cut-away side view of the handpiece in use with themesh deployment applicator.

FIGS. 26A and 26B depict the handpiece and guidance track for use with afluid injection device.

FIGS. 27A through 27D depict a method of using the handpiece and cuttingtool on a dermis, including partially overlapping adjacent treatmentareas.

FIG. 28A depicts one embodiment of a dissection device used in a methodfor severing an endocrine sweat gland and FIGS. 28B-28D depictflowcharts of methods to perform subcutaneous surgery.

FIG. 29 depicts a cross sectional view of skin affected by acne scars.

FIGS. 30A-30D depict a method to treat acne scars.

FIG. 31 depicts a position of a handpiece and guidance track on a skinarea in the treatment of acne.

FIG. 32A depicts an area of peri-orbital skin affected by crow's feetwrinkles.

FIG. 32B depicts a position of a handpiece and guidance track on a skinarea in the treatment of crow's feet wrinkles.

FIG. 33 depicts a position of a handpiece and guidance track on a skinarea in the treatment of a laughing line wrinkle.

FIGS. 34A-34B depict a cross-sectional view of skin with irregularitiesdue to previous liposuction and a treatment step.

FIGS. 35A-35B depict cross-sectional views of skin in a method of theinvention directed at dissipating local tension at the site of a suturedwound.

FIGS. 36A-36B depict a cross-sectional view of skin with an eccrinesweat gland and an innervating nerve bundle and a cross sectional viewof an RF nerve ablation

FIGS. 37A-37B depict a method to apply a vacuum assisted suction forceon a treated area of skin in a post-procedural treatment.

FIGS. 38A-38E depict a method for creating a subcutaneous pocket and theplacement of an implant.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general, the device and methods described here are used to minimallyinvasively create a planar dissection at a defined depth below thedermis. In particular, the plane of dissection may be created generallyparallel to and at a predefined depth below the dermis. Alternatively aplane of dissection may be created at an angle or in a curved shaperelative to the surface of the dermis. Throughout this applicationreference to a depth below the dermis or the like should be understoodto refer to a depth measured orthogonally from the exterior surface ofthe skin. In addition, the term “planar dissection” may mean that thesurface of the dissection lies within a single plane, but alternativelymay mean that the surface of dissection lies in multiple planes or has acurvature, e.g. a cylindrical or spherical shape, or other geometryextending across an area beneath the skin such that an upper layercloser to the skin surface is separated from a lower layer by the planardissection. It should also be noted that the utility of the devicesdisclosed extends beyond treatment of the specific anatomical structuresor physiological conditions described here.

The device and methods may additionally be used to enlarge the tissuepocket created by the dissection by applying a vacuum assisted suctionforce to the handpiece during the performance of the dissection andlifting the skin after the dissection is completed. Application ofvacuum on the skin during the dissection process may put traction on theunderlying tissues, may better align the fibrous septae for dissectionwith the cutting tool, and may allow for uniform and instantaneousseparation of the dissected tissue layers. Additionally, devices andmethods are disclosed for applying vacuum to a skin area overlyingtreated subcutaneous tissue after creation of the dissection.

According to some embodiments it may also be desirable to employ energysuch as Radiofrequency (hereinafter “RF”), to provide the dissectionmeans. The energy can be configured to provide coagulation or acontrolled thermal injury, which in turn may provide fat celldamage/shrinkage or create a more fibrous layer directly or throughwound healing processes. Thermal energy may particularly enhance theeffect of the treatment where tissue destruction or ablation isdesirable. Embodiments of the invention may allow a physician to selectfrom a range of tools that are capable of creating dissections,achieving coagulation and hemostasis or a combination of these treatmentmodalities, thereby enabling the physician to tailor the treatment tothe individual patient without limitations due to the embodiment of theinvention used to implement the procedure.

If desired, a fluid may be injected into the pocket created by thedissection. The fluid may be actively injected, for instance by using asyringe, or may be drawn into the pocket from an external reservoir bythe reduced pressure created by a vacuum applied to the handpiece. Thefluid may perform a number of functions, including enlarging thesubcutaneous tissue pocket, providing structural support, and affectingthe biological response to the procedure by means of an activepharmaceutical ingredient (API).

It should be understood the term “may” as used throughout thespecification refers to an optional feature or component.

As illustrated by FIGS. 1A through 1C, the embodiments utilize ahandpiece 100 to capture and control a location of the skin, or dermis101, as well as precisely control use of a cutting tool 102. Thehandpiece preferably has a top 103 and a perimeter elevation 104 thatcooperatively define a recessed area 105 which can be placed over thedermis of a patient. By applying a force 106 to the top of the handpieceor by a vacuum supplied to the handpiece, a portion of the dermis 101can be moved into the recessed area to substantially fill the recessedarea, thus capturing it within the handpiece and providing some controlover the area of tissue captured. This allows a distal portion ofcutting tool 102 or other suitable dissection device to be insertedthrough a conduit 107 extending through a side of the perimeterelevation of the handpiece, percutaneously through the tissue disposedin the recessed area, and into the subcutaneous tissues encompassed bythe recessed area of the handpiece. Cutting tool 102 is maneuvered insuch a way as to cut a surgical lesion of a predetermined shape insidethe subcutaneous tissues within the recessed area and parallel to thetop of the handpiece. The surgical lesion (dissection) is targeted to bein a range from as shallow as at 1 mm to 2 mm below the interfacebetween the dermis and the shallow fat, to as deep as 20 mm below theskin/fat interface. Applicants hereby define percutaneous to mean apuncture or incision through the skin of between 0.4 mm and 4.0 mm. Itshould be understood that handpiece 100 may be used in conjunction withany of the dissection devices disclosed herein.

Turning to FIG. 2A, a top wall 201 and perimeter wall 202 define atissue apposition surface (tissue facing surface) 203 facing intorecessed area 105. Tissue apposition surface 203 may be curved inward tothe handpiece, or concave, or recessed, so that when handpiece 100 isdisposed against an epidermis 204, further pressure against thehandpiece 100 will cause the handpiece to encompass a subcutaneous levelof tissue 205, particularly the subdermal tissue layer below theepidermis and dermis layers, wherein these layers will be positionedwithin recessed area 105. In some embodiments tissue apposition surface203 includes perimeter wall 202 as a relatively small inner wall aroundthe perimeter of recessed area 105. In some embodiments, handpiece 100may include a transparent cover 206 so that a physician can clearly seeand verify that the dermis is properly positioned within the dissectionregion. In the depicted embodiments, the perimeter walls (sidewalls) ofthe handpiece are shown generally circular. However, one of ordinaryskill in the art will appreciate that the handpiece can be any shape.

The device further allows for three-dimensional control of treatment oranesthetic fluid delivery and dissection of subcutaneous tissues, notrealized by present art. The device typically controls a depth 215 ofbetween 4 mm and 20 mm below the surface of skin (measured orthogonallyfrom the dermis); but a depth less than 4 mm or greater than 20 mm isalso contemplated. Depth 215 is generally defined as being measured fromtissue apposition surface 203. For the purpose of this disclosure,however, the measurement is taken when epidermis 204 is flush againstapposition surface 203 and the thickness of epidermis is considerednegligible. As such, depth 215 can also be considered to be a depthbelow the surface of the skin or a depth below epidermis 204. The rangeof motion in the lateral direction is controlled by the length andmovement of the cutting blade and/or RF probe, however, typicallyencompasses a length of between 2 mm and 100 mm in either direction. Asthe needle/blade/probe is disposed further into the skin larger arcs areachieved.

Generally, device 100 is pressed against the tissue to move thesubcutaneous layer 205 into recessed area 105 and against tissueapposition surface 203. In some embodiments, vacuum (suction) is used toenhance the capture of the tissue. A vacuum source 1606 (FIG. 16B) maybe placed in fluid connection with handpiece 100 via an optional vacuumport 208 on handpiece 100. The vacuum source may include a vacuum pumpin fluid communication with recessed area 105. Vacuum pump 1606 suppliessuction to the recessed area to pull tissue snugly and securely therein.In some embodiments, the vacuum pump is configured to communicate with amicroprocessor 1501 (e.g., FIG. 15) and the graphical user interface1502 to display a vacuum pressure. The system may further include adisplay indicating the elapsed amount of time vacuum was supplied to thehandpiece by the vacuum pump. The vacuum pump may also modulate thesuction such that a higher suction force is applied initially to pullthe tissue into the recess, and a somewhat lower suction force is usedto maintain/hold the tissue in place thereafter.

Vacuum port 208 may be located in the top wall 201 and/or the perimeterwall 202 of handpiece 100. In some embodiments, tissue appositionsurface 203 includes two or more vacuum ports 208 disposed on itssurface and configured to apply suction from the vacuum source to therecessed area and to the tissue from different locations of thehandpiece.

In the embodiment depicted by FIG. 2A, handpiece 100 is seen in use witha vacuum pressure (suction) applied to a portion of skin 101. Suctionapplied at vacuum port 208 causes skin 101 to be pulled up into contactwith apposition surface 205 of handpiece 100. By applying a sufficientsuction force, a portion of epidermis 204 is pulled into the chamber ofvacuum handpiece 100 and conforms to inner recessed area 105. While thesurface of the skin 204 is tightly positioned against top wall 201 andperimeter wall 202 of recessed area 105, fat layer 205 (subcutaneoustissue) is also drawn into the chamber. A cutting tool 102 (e.g., acutting blade or RF probe, or needle), can be inserted through a conduit213 in a side of handpiece 100 and through entry hole 214, through theskin, and into the subcutaneous tissue. Significantly, the handpieceenables the cutting tool to be consistently inserted at desiredtreatment depth 215. Handpiece 100 thus provides for precise control ofthe depth of the dissection plane and allows for cutting and/or movementof tool 102 substantially parallel to the surface of the tissue along aplane 225 (FIG. 2B).

A membrane 217 formed of a flexible and resilient material may also beapplied to the perimeter wall (sidewall) across the proximal (away fromthe recessed area) or distal ends (closer to the recessed area) of theconduit 213 to minimize vacuum leakage there through. The membrane 217preferably is sufficiently resilient to seal around the cutting tool asit pierces (self-sealing) therethrough and minimize vacuum leakage.Membrane 217 may be formed of silicone. However, one of ordinary skillin the art will appreciate that other materials may be use to create theself-sealing membrane.

Conduit 213 is disposed in sidewall 202 of handpiece 100, preferably,adjacent bottom or side portion of tissue apposition surface 203. Insome embodiments conduit 213 is a through hole defined in perimeter wall202 or in top wall 201. In other embodiments, conduit 213 is a tube-likemember inserted into and/or mounted to a through hole in the perimeteror top wall. Conduit 213 is configured to allow passage of a hypodermicneedle, subdermal catheter, cutting tool (as described above), insertiontool, or other appropriately configured tool through the conduit andinto recessed area 105 of the device. The tool may pass through conduit213 just enough to penetrate the tissue.

Conduit 213 is preferably located proximate a bottom edge 218 ofperimeter wall (sidewall) 202 to allow a cutting tool or needle to beinserted into the tissue (captured in the recessed area) in a planeparallel to the dermis. In some embodiments conduit 213 supplies anangle of penetration 219 so that the tool inserted through the conduitwill penetrate into tissue disposed within the recessed area, andsubstantially parallel to the surface of the tissue and parallel to thesurface of top wall 201 at depth 215. Specifically, this configurationmay provide stability of the tool to maintain an even level, e.g., whenthe cutting tool is cutting the fibrous structures 220 between theepidermis 204 (and dermis) and the subdermal fat 221. In someembodiments, conduit 213 provides an angle of entry to bias the plane ofdissection toward or away from the dermis.

As depicted in FIG. 2B, entry hole 214 is preferably disposed on aninner side of the conduit and facing the recessed area. Conduit 213preferably widens outward toward an outer side of the perimeterelevation such that a distal end 222 of the cutting tool insertedthrough the entry hole moves in one direction 223 when a proximal end ofthe cutting tool outside the conduit moves in an opposite direction 224.Entry hole 214 thereby defines a cutting tool pivot point when a distalend 222 of cutting tool 102 is inserted through conduit 213 and intorecessed area 105, and the tool moves primarily in an x-y plane 225parallel to the top surface of the handpiece. In some embodiments entryhole 214 may include an optional locking mechanism 226 that locks thetool in place upon insertion into the conduit. In some embodiments inwhich a vacuum is supplied to the recessed area, an optional gasket orseal 217 (not shown in FIG. 2B) may be placed within, in front of,behind, or around entry hole 214 to minimize vacuum leakage.

In some embodiments conduit 213 constrains side-to-side movement of atool such that movement of the tool through the conduit is limited to abackward direction 227 and forward direction 228. In some embodimentsconduit 213 constrains upward and downward movement of a tool such thatmovement of the tool to maintain the tool in a plane parallel to thesurface of the skin 225. In other embodiments, conduit 213 is configuredto allow the cutting tool to be moved in an arc 223 parallel to therecessed area of the tissue facing (apposition) surface so as to allowcutting within a subdermal area substantially the size of the recessedsurface area.

In some embodiments, conduit 213 has a tool control mechanism (notshown) which allows cutting tool 102 or other tool appropriatelyconfigured device, to be controlled by a microprocessor. In such anembodiment handpiece 100 and/or the microprocessor (not shown) controlscutting device 102 to precisely cut an area of tissue disposed withinrecessed area 105. The area being cut is predetermined and programmedinto the microprocessor by the operator of the handpiece.

As depicted in FIGS. 3A and 3B, the dissection system may include amotor controlled cutting module 301 and a guidance 302 track operablyconnected to handpiece 100. In this embodiment, the cutter moduleincludes an embodiment of cutting tool 102 (a reciprocating cuttingblade 303 disposed in a sleeve 304) and a housing 305 and a base 306.Guidance track 302 is generally configured to constrain a portion of thecutting module guide pin 307 in contact with the guidance track to movealong a predetermined path. Thus, a distal end of the cutting tool,passing through entry hole 214, cooperatively moves within recessed area105 in a plane substantially parallel to the top of the handpiece andwithin a region of a predetermined shape defined by the predefined path.Motor operation of cutting module 301 is preferably controlled manuallyby an electric switch or button 308, but may also be activated byelectrical or other contact means known in the art within the guidancetrack.

FIG. 4 depicts an exploded view of cutting module 301. Cutter module 301includes housing enclosure 305 and base 306, motor assembly 401 mountedon the base and enclosed by the housing, and a reciprocating cuttingblade 303 operably connected to motor assembly 401. Cutting blade 303 isslidably disposed within sleeve 304. Sleeve 304 minimizes the amount oftissue in direct contact with the shaft 402 of the cutting blade 303 tominimize drag and or tugging on the tissue. Sleeve 304 also enables theisolation and/or capture of any fluid that may travel along the shaft ofblade 303.

A motor assembly 401 is enclosed in enclosure 305 and base 306. Sleeve304 is affixed at a distal end 403 of motor assembly 401. In oneembodiment, motor 404 is a DC motor which may incorporate a gearreduction. In the depicted embodiment, a crank slider 405 converts motorrotation to cutter reciprocation. However, it should be understood thatother designs which convert rotary to reciprocating motion (e.g., Scotchyoke) may also be employed. Motor 404, within enclosure 305 movesreciprocating cutter blade 303 within sleeve 304. As the motor turns,crank slider 405 moves cutter 303 back and forth within sleeve 304.Cutter blade 303 may include a needle or a bayonet which may furtherinclude one or more sharp edges.

As depicted by FIGS. 5A and 5B, sleeve 304 does not reciprocate and istypically comprised of a thin-walled polymer tube and is sterile forsingle patient use. Sleeve 304 and cutter blade 303 are typicallydisposable. Sleeve 304 may be affixed to cutter module 301 (and/or crankslider 405) by means of connection point 406. Connection point 406 maybe a disposable protective connector keeping cutter module 301 and gearmotor assembly 401 in fluid isolation from sleeve 304 and cutting blade303. For instance, connector 406 may also include a barrier (not shown)enclosing cutting module 301 during operation of the device. In thismanner, cutting blade 303 and sleeve 304 could be disposed along withconnection point 406 after each procedure. Correspondingly, cuttingmodule 301 including motor assembly 401 and base 306 could be reused insubsequent procedures. In another embodiment, cutting blade 303, sleeve304, and crank slider 405 may be incorporated into base 306 such thatthe combined assembly is separate from and operably coupled to the motor404. In this manner the assembly could be disposed of after eachprocedure. Radiofrequency identification (RFID) or other interlock couldprevent re-use of the blade assembly. In some embodiments cutting blade303 is a bayonet. In other embodiments, a cutting means, such as an RFcutting device, harmonic scalpel, or similar cutting means may besubstituted for or used in conjunction with the blade and/or bayonet. Ifan RF cutting device is used then the device is operably connected to anRF amplifier (see FIG. 16B).

With reference to FIGS. 3A and 3B, the handpiece also preferablyincludes a platform 309 integral with or affixed to a proximal side ofhandpiece 100. Platform 309 may be affixed to handpiece 100, forexample, by screws 310 (e.g., Allen screws), a clip mechanism 1209, 1210(FIG. 12), or any other similar fastening means. Platform 309 preferablyincludes guidance track 302, wherein guidance track 302 is used toposition, guide, and support cutting module 301 by means of a guide pin307. Guide pin 307 moves within and along the path of guidance track 301to stabilize the cutter module at a proper position proximate tohandpiece 100. FIG. 3B depicts the bottom portions of the handpiece 100and cutter module 301. Guide pin 307 is located on a side of base 306proximal to sleeve 304. In the depicted embodiments, guide pin 307 is anprotruding feature that interfaces with, or is received by, guidancetrack 302; however, guide pin is defined herein to be any feature whichengages guidance track 302 such as to provide a defined movement of thecutting tool along a predetermined path. For example, guide pin may be arecess or groove wherein guidance track is a raised edge or ridge alongguidance track 302 so that the cutting module rides along the raisedguidance track to move the cutting tool along the predetermined path.

In this embodiment, guide pin 307 protrudes through base 306 of cuttermodule 301, however, in other embodiments guide pin 307 may be part ofbase 306 or cutting module 301. The guide pin may serve dual purposes.Guide pin 307 serves to guide the disclosed cutting module embodimentsto create a surgical lesion defined by the path of guidance track 302.Additionally, the guide pin may include a feature such as an enlargedhead or the like which interacts with guidance track 302 and preventscutting module 301 from being lifted off the platform 309 and/orsupports cutting module 301 at a predefined planar orientation relativeto platform 309. In the drawings, guidance track 302 holds cuttingmodule 301 such that the cutter blade 303 creates a lesion parallel totissue apposition surface 203, i.e., parallel to the dermis. However,the guidance track 302 could also hold the cutting module such that thecutting blade creates a lesion at a different predefined orientationrelative to the dermis. In another embodiment, the guide pin could bemotorized and assist or automate the movement of the cutting modulethrough the guidance track.

Turning now to FIGS. 6A and 6B, in one embodiment, the path of guidancetrack 302 is defined by a central channel 601 passing through multiplearcs 602, the arcs each having a radius measured from a center pointlocated beyond the guidance track in a direction toward the portion ofthe cutting tool that will provide the cutting action. Moving toward thecenter point, each successive arc 602 decreases in length and growssmaller. In this embodiment, the penultimate arc is joined with a finalinverted arc 603 of the same size to create a closed loop between thepenultimate arc and final inverted arc. Central channel 601 does notintersect with inverted arc 603, but, rather, guide pin 307 moving alongthe path of central channel 601 will move into the final inverted arc bytraveling along and beyond an end of the penultimate arc. In thedepicted embodiment there are three primary arcs, the last joining theinverted arc. Central channel 601 also has an enlarged opening 604 atits starting position, furthest from the arcs, wherein the centralchannel is in the form of an elongated substantially straight trackmoving toward the arcs. This straightened portion allows the cuttingmodule to be positioned within the track at its beginning and to move ina forward direction to insert the cutting tool through the conduit andentry point and into the recessed area. Central channel 601 is alsostaggered between the first and second arcs and between the second andthird arcs to prevent a cutting module traveling along the guidancetrack from slipping further forward to the last arc before providing theoperator of the cutting module the opportunity to move the cuttingmodule in the entire range of the predefined path. In those embodimentsin which guide pin 307 has an enlarged head, enlarged opening of thecenter channel is suitable for receiving the enlarged head, and guidancetrack 302 includes an enlarged underside for passage of the enlargedhead along the path while preventing the cutting module from beinglifted off platform 309 and/or supports cutting module 301 at apredefined planar orientation relative to platform 309. In an alternateembodiment, the arcs of guidance track 302 are connected at the outeredges to allow alternate movements of the cutting module between thetracks. This is particularly useful once the dissection is complete sothat the motor can be easily moved from the last inverted act to centralchannel 601.

In alternate embodiments, with continued reference to FIGS. 6A and 6B,guidance track 302 may be removable and replaced with a differentpattern which creates a different dissection profile. For instance, avariety of guidance track inserts may be provided so the physician cantailor the procedure to the patient's anatomy and/or the size of thelesion to be created. Guidance track 302 may be inserted into apredefined indentation or cutout 605 in platform 309 and constrained bya locking mechanism 606. The mechanism may include the platform havingpivoting arms or levers 607 which rotate within an indentation 608 tooverlap a portion of guidance track 302 to constrain it within theplatform cutout. FIG. 6A depicts one embodiment of the platform having aremovable guidance track 302 with a predetermined path for use with acutting tool to cut a predetermined shape defined by the predefinedpath. FIG. 6B depicts an embodiment of the platform having a removableguidance track with a predetermined path for use with an injectiondevice to coordinate movement of a complimentary device having ahypodermic needle or other injection device to inject a fluid within atissue disposed within the recessed area in a treatment area defined bythe predefined path.

Turning briefly to FIG. 12, platform 309, including guidance track 302,may also be removably detachable from handpiece 100 by a clippingmechanism. In this embodiment, handpiece may include locking receivingspaces 1209 configured to receive complementary insertable clips 1210affixed to platform 309. Clips 1210 may be made of a bendable material(e.g., plastic or flexible alloy) and face outward from platform 309 atits handpiece facing end 1211. Handpiece is formed such that receivingspaces 1209 are integrally formed from the body 1212 of handpiece 100,in a gap left open between the perimeter wall 104 and recessed area 104and an outer surface of body 1212. A user wishing to attach or detachplatform 309 from handpiece 100 need only cooperatively squeeze clips1210 inward while inserting or removing them from receiving spaces 1209.Releasing clips 1210 while they are inserted in receiving spaces 1209will lock platform 309 against handpiece 100.

FIG. 7 depicts the cutting module in use with the guidance track to cutwithin subcutaneous tissue.

layers 205 at depth 215. Sleeve 304 passes through entry hole 214 ofhandpiece 100, effectively creating a pivot at the point 801 of contactwith the skin. With additional reference to FIGS. 8A through 8C, conduit213 is wider at a point furthest from entry hole 214. This allowscutting implement 102 or cutting module 301 to pivot about entry hole214 and move within the desired treatment area 802. Guide pin 307 on theunderside of cutting module 301 is engaged into guidance track 302 ofplatform 309. Accordingly, the bottom of cutter module 301 remains incontact with platform 309 during operation, thus constraining the cutterto operate only in a plane at the desired depth. Engagement between pinand track, combined with pivot at shaft entry hole 214, constrains thecutter to only operate within the desired region. Guide track 302 may beconstructed in any number of ways consistent with the practice of theinvention. The shape of guide track 302 is not limited to thoseillustrated by the accompanying figures herein. In some embodimentsguide track 302 may be undercut and guide pin 307 may include a flangesuch that the interface between the flange and the undercut preventscutter module 301 from being lifted off from platform 309 and/orhandpiece 100.

Cutting region 802 is dependent upon conduit 213 such that, as cuttingdevice 102 is constrained by entry hole 214, it is also constrained byguide pin 307 to move along guidance track 302. Accordingly, the cuttingtool moves in a side to side fashion to allow a distal end of the device(including a cutting device, e.g., needle, blade, RF cutter, water jet,laser, ultrasonic or harmonic scalpel) to move along the maximumboundary (laterally and longitudinally) of cutting region 802. FIG. 8Ashows the cutting blade entering into cutting region 802. Guide pin 307is engaged in guidance track 302 as cutting module 301 is advanced inthe Y direction 803 until guide pin 307 reaches the proximal arc of thetrack. At this point, the cutting blade is through the skin and themotor is energized to commence reciprocation of the blade. In furtherembodiments, the guidance track incorporates a contact (e.g., a sensor)to prevent premature powering of the motor module, or automated poweringof the motor module when the motor module has reached the appropriateportion of the guidance track.

As cutter module 301 is advanced toward the handpiece pin 307 movesalong and is restricted by guidance track 302, such that, as depicted byFIG. 8B, as guide pin 307 moves within guidance track 302, a distal endof the cutting tool will move from side to side inside cutting region802 in a controlled fashion. The path of guidance track 302 defines thesize and shape of region 802. Taking the z-axis as the centerline of thehandpiece from top to bottom, the path preferably restricts movement ofthe cutting module, and, thus, the cutting tool moves in an x and ydirection within a plane parallel to the top of the handpiece. Theinteraction between pin 307 and track 302 defines a maximum width 804,or x direction. A physician moves cutting module 301 along the track bybeginning the cutting just inside the skin and, following the track towork inward, the fixed (non-cutting) portion of the shaft is alwayswithin a region where the tissue is separated; otherwise, theunseparated tissue will prevent the shaft from pivoting freely over thedesired region.

As shown in FIG. 8C, interaction between the pin 307 and the track 302also defines a maximum length 805, or y direction, of the region 802.The path of guide track 302 preferably defines the region in which thecutting tool will move within the recessed area of the handpiece. Thegeometry of the track in conjunction with the length of the blade andreciprocation stroke defines the dissection area. After following theentire track the motor is turned off and the cutter is removed. Afterthe power is turned off and prior to removal of the cutter, thedissection can be confirmed by retracing the path with the motor moduleoff. The power may be turned back on to cut any areas not previouslyreleased. This same method would apply to any cutting instrumentdisclosed herein. In the depicted embodiment, the overall resultingregion 802 is tear-dropped shaped. However, the path of guidance track302 and/or conduit 213 and/or entry point 214 can be altered to modifythe shape of region 802 to take the form of any shape.

An alternate range of motion may be enabled by selection of the guidancetracks illustrated in FIGS. 6A and 6B. A physician may also choose torestrict the motor module within the multiple arcs 602 and not completethe outer regions of any one of the arcs. The staggered central track601 may still be used to advance the module toward the final invertedarc 603. In a further method, the physician may choose to not completesuccessive arc(s). Thus, by these methods, a reduced area of dissectioncan be created.

FIGS. 9A through 9C depict an embodiment of platform 309 and guidancetrack 302.

In this embodiment guidance track 302 is a semi-ovoid shape formed alongan outer edge 901 of platform 309. Guide pin 307 is positioned on a sideof the cutting device (e.g., cutting implement 102 or sleeve 304) suchthat guide pin 307 moves along the curvature of guidance track 302 andsuch that the dissection can only occur within the defined boundary 902(similar to FIGS. 8A to 8C). Although FIGS. 9A through 9C depict theguidance track used with an anesthesia needle, it should be recognizedthat the depicted guidance track (or any guidance track disclosedherein) can be used with either an anesthesia needle or any cuttinginstrument disclosed herein.

In a further embodiment of platform 309, depicted by FIGS. 10A and 10B,guidance track 302 is configured to provide a controlled delivery oftreatment fluid through needle 1001. Needle 1001 may be a tube, anhypodermic needle and may have a multitude of holes for increasedlateral fluid dispersion. A supply tube 1002 provides fluid connectionof needle 1001 with a syringe 1003, syringe pump, roller pump or otherinjection mechanism known in the art. In certain embodiments, a needlecontrol module 1004 is included to house needle 1001 and to providesupport for movement along guidance track 302. Movement of needle 1001along guidance track 302 provides delivery of the treatment fluid inprecise locations of the dissection region and minimizes the amount ofinfusion fluid required for a single treatment and/or over multipletreatment sites. Needle control module 1004 preferably includes a guidepin to be engaged into guidance track 302 of platform 309. The guide pinguides the needle/cannula to insure that the injectable fluid isinjected into the tissue at the desire depth and desired locationswithin a predefined treatment area defined by the path of guidance track302.

An embodiment of guidance track 302 for use with needle control module1004 includes three radial channels 1005 converging toward a centerpoint located beyond the guidance track in a direction toward theportion of the needle delivering the fluid to the treatment area. Acentral channel provides a straightened portion 1006 that allows theguide pin of needle control module 1004 to be positioned within thetrack at its beginning and to move in a forward direction to insertneedle 1001 through conduit 213 and entry point 214 and into therecessed area. Downward from the starting position of the centralchannel, the central channel intersects and passes through a crosschannel 1007. In this embodiment, cross channel 1007 is in the shape ofa wide arc having a center in a direction toward the center point. Aradial channel begins at each end of the cross channel such that a guidepin moving along the path of the cross channel will move into a radialchannel by traveling along and beyond an end of the cross channel. Eachradial channel converges toward the central channel as the needlecontrol module moves in a direction toward the center point. An enlargedopening 1008 of the central channel marks the starting point of thecentral channel. In those embodiments in which the guide pin has anenlarged head, the enlarged opening of the center channel is suitablefor receiving enlarged head, and the guidance track has an enlargedunderside for passage of the enlarged head along the path whilepreventing the cutting module from being lifted off platform 309 and/orsupports the needle control 1004 module 1004 at a predefined planarorientation relative to platform 309.

In one embodiment, with continued reference to FIGS. 10A and 10B, whenthe guide pin on needle control module 1004 reaches cross path 1007along the central channel 1006, the needle has pierced the skin capturedin recess 105. When the guide pin is moved along cross channel 1007, theneedle rotates within the pierced area, but does not move forward orexit the skin. Therefore, when the needle is moved by control module1004 down a converging radial channel and back, cross channel 1007provides a stop which maintains the needle within the skin. In thismanner, fluid may be infused over the entire area through a singleneedle puncture. In a further embodiment, with reference to FIG. 12A,central channel 1006 stops at cross path 1007, and four convergingradial channels 1005 can be used for fluid infusion. In this manner, allthe converging channels 1005 start and stop, and cross path 1007prevents the needle from being withdrawn from the skin by requiring theguide pin on control module 1004 to move directly across cross path 1007from a radial channel to central channel 1006.

FIGS. 11A through 11D depict a yet further embodiment of the platform.In this embodiment, platform 309 of the previous embodiments is replacedby support arm 1101 movably coupled to handpiece 100. Support arm 1101includes a guide pin 1102 which interacts with a guidance track 1103defined in the top portion of the handpiece 100. A handle 1104 is usedto advance support arm 1101 as guided by the interaction of the guidepin 1102 and guidance track 1103. Guide pin 1102 moves within and alongguidance track 1103 to stabilize a cutter module 1105 at a properposition proximate to handpiece 100. Cutter module 1105 can be adaptedto use any cutting mechanism disclosed herein. In one aspect cuttermodule 1105 may include cutting implement 102. In another aspect cuttingmodule 1105 is manually controlled. In the depicted embodiment cuttingmodule 1105 is motor controlled and includes a housing, a gear motor,cutting blade 1106, and sleeve 1107 similar to the embodiment depictedby FIGS. 3 and 4. Guide pin 1102 is located on a lower side of supportarm 1101 proximal to sleeve 1107. Cutting module 1105 is fixed tosupport arm 1101 and thus the support arm is moved to advance cuttingblade 1106. In certain aspects cutting module 1105 may include an RFcutter. The compact size of this third embodiment is particularly suitedto facial applications.

In further embodiments of the platform, the handpiece may not have aperimeter wall and/or a defined recessed area. In such embodiments,handpiece 100 may include an apposition platform for covering a portionof the dermis to be treated. The apposition platform may include aguidance track 1103 and support arm 1101 to support the cutting toolfrom above. In some embodiments the perimeter wall does not encompassthe entire perimeter of the device, but, rather, encompasses only whatis necessary to support conduit 213 and/or entry hole 214. In someembodiments, the platform and guidance track are omitted completely,and, stability and control of cutting tool and cutting below theapposition platform is achieved by manual operation and skill of themedical practitioner operating the device.

Some embodiments of handpiece may include an adjustable top or lid tochange the distance between an inner side of the top of the handpieceand the bottom edge of the perimeter elevation of the handpiece.Moreover, in such embodiments, the top of the handpiece 100 isadjustable in relation entry point 214 of conduit 213 to adjust thevolume of recessed area 105 and the depth 215 at which cutting tool 102cuts the subcutaneous tissue when inserted through conduit 213.

In some embodiments, depicted by FIG. 12, the handpiece includes areversible lid 1201. In the depicted embodiment, lid 1201 has a recessedside 1202 and a raised side 1203. Both sides of lid 1201 are configuredto fit snuggly over perimeter wall 104 such as to be easily removed yetmaintain a airtight seal to prevent vacuum leakage when a vacuum issupplied to handpiece 100. Depending on which side of lid 1201 ispositioned over perimeter wall 104, depth 215 of recessed area 105 willvary. Recessed side 1202 has a shallow rim 1204 which is sized to fitthe profile of a top 1205 of perimeter wall 104. When lid 1201 issecured to handpiece 100 with recessed side 1202 faced downward andtoward recessed area 105, depth 215 is increased and the volume ofrecessed area 105 is correspondingly enlarged. Conversely, raised side1203 has a platform 1206 which is sized to snugly fit within the profileof top 1205 of perimeter wall 104. When lid 1201 is secured to handpiece100 with raised side 1203 faced downward and toward recessed area 105,depth 215 is decreased and the volume of recessed area 105 iscorrespondingly reduced. As in the depicted embodiment, handpiece mayfurther include latches 1207, spaced about the perimeter of top 1205 ofperimeter wall 104 to securely fasten lid 1201 to handpiece 100 viacorresponding locking apertures 1208. Each corresponding lockingaperture 1208 is configured to receive a latch 1207 such that when latch1207 is inserted into aperture 1208 and lid 1201 is subsequently rotated1209, latch 1207 becomes locked within aperture 1208, and lid 1201 issecured with respect to the latch-aperture communication.

Accordingly, lid 1201 is reversible so that to change depth 215 theoperator of the handpiece needs only remove the lid, flip it over, andre-attach it. In some embodiments, an o-ring (not shown) or rubber-likematerial may optionally be interposed on lid 1201 about rim 1204 and/orplatform 1206, or about top 1205 of perimeter wall 104, to provide asecure fit and/or prevent vacuum leakage. In further embodiments,several lids may be provided with multiple and varying recess areas toallow depth to be changed, whether the lids are reversible or not.

In a further embodiment, depicted by FIGS. 13A and 13B, an inflatablebladder 1301 conforms to the inner diameter of handpiece 100 and isdisposed between a rigid outer lid 1302 and a rigid inner lid 1303.Inner lid 1303 is slidably disposed inside the circumference ofhandpiece 100 whereas rigid outer lid is rigidly mounted to theperimeter wall 1304. Tubing 1305 fluidically connects bladder 1301 topressure source (not shown) for inflation of bladder 1301. Inflatablebladder 1301, rigid outer lid 1302, and rigid inner lid 1303 are thenpositioned to fit into the top of handpiece 100, with tubing 1305protruding through a port or an upper indentation 1306 located along theupper rim portion 1307 of perimeter wall 1304. These components fittogether such that rigid outer lid 1302 is coupled to perimeter wall1304 of handpiece 100, and enclosing bladder 1301 and rigid inner lid1303 are slidably disposed within handpiece 100. As can be seen by FIG.13B, adjustment of pressure in bladder 1301 causes inner lid 1303 toraise or lower 1308, correspondingly, thereby changing the volume ofrecessed area 105 and allowing for selection of a desired dissectiondepth.

In a yet further embodiment, depicted in FIGS. 14A and 14B, thehandpiece includes a threaded engagement 1401 between a threaded lid1402 and open perimeter wall 1403 of the handpiece. Lid 1402 is threadedonto the upper rim 1404 of wall 1403 similar to a food jar. Lid 1402includes an outer edge and an inner edge 1405 which grasps rim 1404. Lid1402 may further include a recessed area 1406 defined by thecircumference of inner edge 1405. An interior side 1407 of recessed area1406, along with an associated portion of perimeter wall 1403 makes uppreviously described tissue apposition surface 203. Rim 1404 is threadedsuch that, as lid 1402 is rotated 1408, recessed area 1406 (includingtissue apposition surface 203) moves in direction 1409 (orthogonal tothe dermis) to a desired depth within handpiece 100. An optional o-ring1410 may be positioned along the outer circumference of inner edge 1405,between inner edge 1405 and an inner side of rim 1404 to prevent leakingof vacuum applied to the device. Threaded lid 1402 may further includereference numerals (e.g., 9 mm, 10 mm, etc.) defining the depths oftissue apposition surface 203 as lid 1402 is rotated. A reference mark1411 is placed on the body of handpiece 100 to mark and indicate thecurrent depth setting. Lid 1402 may include further complimentarymarkings 1412 to be aligned with mark 1411 at various depths.

In a yet further embodiment, the depth is adjustable by way of a slidingplatform that moves the entry of the tool device up or down relative tothe inside of the lid. Based on the depicted embodiments, one ofordinary skill in the art will appreciate that there are other ways toconstruct a variable depth vacuum assisted handpiece and such designsfall within the scope of the device and method disclosed herein.

Turning back to FIGS. 10A and 10B, the device and system may furtherinclude a syringe or syringe pump 1003 connected to needle or cannula1001 and a source of injectable fluids. The treatment fluid may beinjected prior to or after deployment of the cutting tool. The fluid maybe actively injected, for instance by using the syringe, or may be drawninto the pocket from an external reservoir by the reduced pressurecreated by a vacuum applied to the handpiece. The fluid may perform anumber of functions, including enlarging the subcutaneous tissue pocket,providing structural support, and affecting the biological response tothe procedure by means of an active pharmaceutical ingredient (API).Simple enlargement of the tissue pocket may be achieved by the injectionof saline. Support for the pocket and surrounding tissue may be achievedby injection of a fluid containing a liquid polymer formulation toenhance viscosity, or by injection of a suspension of microparticles.Suitable polymers for injection may include commonly used materials forcosmetic and reconstructive surgery, such as collagen and hyaluronicacid. Suitable microparticulate systems may include formulations basedon biodegradable polymers, like poly-lactic acid and poly-glycolic acidand their copolymers, or permanently implanted materials like siliconesor poly-olefins of polyurethanes. APIs may include compounds like localanesthetics, anti-inflammatories, anti-biotics, hemostatics, or healingresponse modifiers like collagen promoters. Multiple functions can becombined in an injected fluid, for instance the polymeric components maybe used as controlled release carriers for the APIs.

The needle or cannula 1001 can be used to inject the injectable fluidinto the tissue prior to, during, or after the creation of a surgicalincision. Accordingly, the needle or cannula may be inserted throughconduit 213 and through entry hole 214, through the skin, and into thesubcutaneous tissue. The needle or cannula may optionally be disposed ona needle control module 1004 for use with an embodiment of guidancetrack 302.

In some embodiments, needle 1001 includes multiple injection ports alonga side of the needle and flush with its outer surface. The ports areconfigured to discharge a fluid in a direction substantially orthogonalto an axis of the needle and in a distribution substantially parallel tothe top of the handpiece. Multiple ports are used to allow a broaderdistribution of fluid delivered by needle control module throughout thearea of treatment during an injection. The fluid will infuse into thesubcutaneous tissues, including the subcutaneous fat and adipose tissue.The ports may, in one embodiment, be aligned on a side of needle 1001 sothat when needle 1001 is positioned in the subcutaneous treatment areait can be further oriented such that the infusion occurs predominatelyin the plane of tissue, parallel to the surface of the skin, ensuringthat the fluid is further distributed over the largest possible area. Inother embodiments, the ports may be staggered. One particular advantageof a staggered configuration is an increased mechanical strength.Another advantage is the ability to infuse fluid throughout thetreatment area without necessitating perfect alignment of needle 1001.In a further embodiment, the needle may include a partially crimped tipfor piercing a dermis while maintaining the ability to discharge thetreatment fluid from the crimped tip while allowing a simultaneousdischarge from the injection ports on its side.

As depicted by FIG. 15, the system may further include a microprocessorunit 1501 having a graphical user interface 1502 to be operablyconnected to and used with injection device 1003, 1004, a source ofinjectable fluid 1503, a microprocessor controller 1504, and, anoptional waste reservoir 1505. A microprocessor and software (not shown)may be included and used to control microprocessor unit 1501 to meterthe infusion according to parameters set by the physician. The systemcan display drug dose or other infusion information and provide warningsor alarms. The needle injection module 1002 and/or a syringe pump 1003communicates with the microprocessor unit 1501 information specifyingthe volume of injectable fluids injected into the tissue. The graphicaluser interface may prompt a user to enter information specifying aconcentration of the injectable fluid and a weight of the patient. Themicroprocessor may include logic for determining a maximum safe dosageof the injectable fluid based on the weight of the patient and theconcentration of the injectable fluid. In one aspect, the microprocessormay also cause graphical user interface 1502 to display at least onewarning message when the volume of fluid injected by the syringe pumpexceeds a predefined threshold which is less than the maximum safedosage and may instruct the syringe pump to terminate injection when thevolume of fluid injected by the syringe pump reaches the maximum safedosage. In yet a further aspect, the graphical user interface may enablethe user to over-ride the maximum safe dosage such that the syringe pumpcontinues injecting the injectable fluids once the maximum safe dosagehas been reached.

The graphical user interface also optionally displays an elapsed amountof time since the injection control module and/or syringe pump initiatedpumping injectable fluids. In some aspects, the microprocessor tracksthe amount of elapsed time since the system initiated pumping injectablefluids and may calculate a recommended treatment start time and arecommended treatment end time. For example, if the injectable fluidincludes anesthesia and or a vasoconstrictor, the microprocessorindicates when the surgical incision can be created, i.e., when theanesthesia is effective. Microprocessor may also use information such asthe volume of injectable fluids pumped by the syringe pump and elapsedtime since the syringe pump initiated pumping injectable fluids todetermine the treatment start time and a recommended treatment end time.Microprocessor 1501 and graphical display 1502 can be further configuredin some embodiments to control and/or display other informationregarding the use of the handpiece or cutting tool. For example,microprocessor 1501 may control the vacuum pump used to capture thetissue in the treatment area and graphical display 1502 may be used todisplay a vacuum pressure or an elapsed time a vacuum has been suppliedto handpiece 100 by the vacuum pump.

In a further embodiment, the device and method may be configured to usea high-pressure stream of fluid such as saline to create the lesion orto sever fibrous septae or disrupt the subcutaneous tissue. A cuttingdevice suitable for use with some aspects of the present invention iscommercially marked by HYDROCISION™. HydroCision's proprietary FLUIDJET™technology is the basis of a new surgical modality, HydroSurgery.HydroSurgery uses a controlled hair-thin supersonic stream of water in aprecise manner to provide an effective cutting, ablation, and collectionsystem for medical applications. HydroSurgery has the power density oflaser and radiofrequency technologies without causing collateral damageto tissue. HydroSurgery also has the unique benefit of simultaneouslycutting, ablating, and removing the targeted tissue and debris.

In some embodiments needle 1001 is configured to increase a kineticenergy of the fluid when it is injected by injection device 1004.Injection device 1004 is guided along guidance track 302 to inject afluid at a high pressure orthogonal to the surface of the dermis, and atdepth 215, to cut fibrous septae 220 located in a treatment area locatedin the subcutaneous tissue 205. It has been determined that a pressureof between 20 and 60 Bar a water-jet with sufficient cutting power tocut 8 mm into subcutaneous tissue in one single pass or rotation of theneedle. Deeper cuts can be achieved by repeated application on the samecut. Water-jet dissection can also lead to a water uptake of the cuttissue. Morphologically all the vessels, lying in the cut are undamagedif the pressure doesn't exceed 40 Bar pressure range. Preferably, thepressure is thus set to be above 50 bar (in the 50 to 60 bar range) toensure that fibrous septae 220 located in the treatment area are cut. Inthis embodiment, needle 1001 includes a nozzle 1506 at a distal end ofthe needle. Preferably, nozzle 1506 is configured to increase a kineticenergy of a fluid injected by the injection device through the needle.In some embodiments, the nozzle is a convergent nozzle. Thus, the throatof the nozzle converges toward the tip of the needle. In otherembodiments the nozzle may be a divergent nozzle and/or be configured toslow the kinetic energy of the fluid injected.

In a yet further embodiment, the device and method may also use thedevice and high powered pressure burst described in, and incorporated byreference from, patent application Ser. No. 12/555,746, filed Sep. 8,2009, which is a continuation-in-part and claims priority from U.S.application Ser. No. 11/515,634, filed Sep. 5, 2006, and from U.S.application Ser. No. 11/334,794, filed Jan. 17, 2006, now U.S. Pat. No.7,588,547, both of which are incorporated by reference in theirentirety.

FIG. 16A depicts an embodiment of the cutting mechanism. In thisembodiment, an RF cutter 1601 is used. In other embodiments, anothercutter such as a harmonic scalpel (e.g. Ultracision® harmonic scalpel)or the like may also be used. RF cutter 1601 may be positioned in aninsulating sleeve 1602 that electrically insulates RF cutter 1601 fromthe body of RF cutting module 1603. In some embodiments, the shaft ornon-cutting portion of RF cutter 1601 may also be coated with anelectrically insulating coating. The body of cutter module 1603 mayinclude a handle 1604 which is also electrically insulated from RFcutter 1601. Cutter module 1603 may include a guide pin 307 (as in FIG.3B), and handle 1604 may be used to guide cutter module 1603 along guidetrack 302. This embodiment illustrates a specialized handle and RFcutting mechanism for use with the guidance track 302 and handpiece 100.Similar to FIGS. 10, and 11A through 11C, guidance pin 814 moves withinguidance track 822 to properly position the RF cutter 1301 within thecutting region. The handle may have control buttons (not shown) whichactivate the coagulation or cutting modes of the RF energy. In someembodiments, the use of a reciprocating motor such as illustrated byFIG. 4 may be used to reciprocate, move, or vibrate RF cutter 1601. Itshould also be understood that, in some embodiments, the RF cutter maybe provided with a reciprocation mechanism or motor control forreciprocating the RF cutter similar to cutter module 301 depicted inFIG. 4.

In some embodiments, RF cutter 1603 may include a bayonet and/or bladeat least partially coated with an insulative coating. For example, ifthe blade/bayonet is two-sided, the insulative coating may cover onlyone side, leaving the other side exposed. An additional benefit ofleaving the side facing the dermis exposed would be to direct additionalenergy upward for skin tightening. An electrical connection point 1605connects RF cutter 1601 by means of an electric cable (not shown) to anRF generator 1609 (FIG. 16B).

FIG. 16B depicts a block diagram of a system for performing subcutaneoussurgery on a patient. The system includes an RF cutting probe 1601, avacuum assisted handpiece 100, and an RF generator 1606. The handpiece100 supports the RF probe such that the probe creates a planar surgicallesion at a predefined depth below the dermis through a minimallyinvasive puncture between 0.4 mm and 4.0 mm in diameter. In other words,the surgical lesion is created without exposing the wound or creating askin flap. Handpiece 100 has a tissue-engaging surface defining a recessconfigured to capture a predefined thickness of tissue. RF cutter 1601is percutaneously inserted into the tissue captured within the recesssuch that the planar surgical lesion is created at a depth defined bythe height of the recess. RF generator 1609 supplies power to the RFcutting probe and includes an impedance measuring circuit for measuringthe impedance of the tissue. The RF generator includes feedback controllogic which may include a hard-wired electronic circuit and/or softwareor microcode on a RAM (random-access memory) or ROM (read-only memory)chip executed by a microprocessor or the like within the RF generator.The feedback control logic optimizes the power supplied to the probebased on the measured impedance such that the RF cutting probe cutsefficiently.

The aforementioned system may further include a thermistor orthermocouple (not shown) which may, for example, be provided on the RFcutting probe 1601. In certain embodiments, the thermistor orthermocouple is preferably operably coupled to RF generator 1609 andcommunicates information indicative of a temperature of the tissue. Thefeedback control stops the RF generator from supplying power to thetissue when a temperature of the tissue reaches a predefined threshold.

The aforementioned system may contain controlled infusion of aconductive fluid, like saline, to provide additional dispersion of theRF energy, maintain tissue impedance, and/or provide anesthetic benefit.

In some embodiments, a monopolar RF electrode may also be used withhandpiece 100 as the return electrode. In this embodiment the systemincludes an active electrode 1601, an RF amplifier 1609, a vacuumassisted handpiece 100, and a vacuum pump 1606. In one embodiment,handpiece 100 may include an electrically conductive layer (not shown)attached to the interior surface 203 of the handpiece such that, in use,the conductive layer is placed in electrical contact with the skin 204.The conductive layer can be a mesh screen affixed to the handpiece orcan be a layer which is sputtered or vacuum deposited on the interiorsurface of the handpiece. According to some embodiments the conductivelayer may be translucent or transparent.

The conductive layer is electrically coupled to RF generator 1609 andthus a conductor electrically coupled to the conductive layer passesthrough an opening in the handpiece or under the handpiece. Theconductive layer may span the entire interior surface of the handpieceor may include one or more windows used to visualize positioning of thehandpiece. The conductive layer may be composed of any electricallyconductive material, such as copper or aluminum, and/or incorporating anelectrically conductive gel. Certain conductive materials may besputtered or vacuum deposited on the handpiece, providing and additionaladvantage of being optically transparent (e.g., indium tin oxide (ITO)).

According to one embodiment, the system includes a handpiece fluidicallycoupled with a vacuum pump 1606 (FIG. 16B), and a needle-like RFelectrode 1601 (FIG. 16A) which is inserted through conduit 213 in thehandpiece for creating a lesions parallel to the surface of the skin andat a depth 215 defined by the handpiece (FIGS. 2A and 2B). RF electrode1601 is coupled to RF generator 1609 which includes impedance feedbackcontrol logic which may be embodied in software and/or hardware orfirmware. The impedance feedback control logic monitors the impedance ofthe tissue and modulates the power delivered to the electrode to preventthe tissue from desiccating, i.e., preventing a premature impedancespike.

In the disclosed embodiments herein, a subdermal pocket is created usingthe aforementioned vacuum handpiece in combination with various cuttingmodalities including cutting blade, laser, high pressure fluid injection(e.g., hydrocision), or RF electrode. After the subdermal pocket iscreated, the cutting tool is swapped for an RF electrode which isoperated in a coagulation mode (as opposed to a cutting mode) to stopany bleeding. Use of the RF electrode in the coagulation mode may resultin contraction of collagen in the tissue leading to skin tightening andmay lyse some of the tissue. Thus, if the subdermal pocket is createdwithin a shallow fat layer then operation of the RF electrode in thecoagulation mode may lyse some adipose tissue. Use of the RF electrodein the coagulation mode may increase the healing response time and maylead to less bruising.

In the aforementioned embodiment, the same RF electrode 1601 may be usedboth to create the subdermal pocket and to induce haemostasis. Namely,RF electrode 1601 may be operated in a cutting mode to create thesubdermal pocket and then may be operated in a coagulation mode tocreate or induce haemostasis.

In one embodiment, depicted by FIG. 17, an inflatable member 1701 havingan RF electrode 1702 provided on an exterior surface thereof is used tofacilitate coagulation. More particularly, a subdermal pocket belowdermis 204 is created using the handpiece 100 in combination with any ofthe aformentioned cutting modalities including cutting blade, laser,high pressure fluid injection (e.g., hydrocision), or RF electrode.Inflatable member 1701 is inflated within the subdermal pocket andelectrode 1702 attached thereto is operated in a coagulation mode tostop any bleeding. It should be understood that the device may alsoutilize a return electrode 1703 placed in contact with the patient'stissue. In some embodiments, return electrode 1703 may be placed in alocation remote from the treatment site. In the depicted embodiment,electrode 1702 includes multiple circular bands disposed about thecircumference of inflatable member 1701. However, it should berecognized that the electrode may take the form of other configurations,for example, one or more linearly disposed bands along the length ofinflatable member 1701. As described above, the vacuum handpiece mayinclude a return electrode, or the return electrode can be a discreteitem separate and remote from the handpiece.

In a further embodiment, the cutting member (i.e., any tool disclosedherein capable of cutting tissue or creating a lesion within tissue) mayinclude an electrode or a heating element. In an embodiment where thecutter includes an electrode, the cutter itself may be the electrode orthe cutter may be a discrete element provided on and electricallyinsulated from the rest of the cutter. In an embodiment where the cutterincludes a heating element such as a resistive heating element, theheating element may be provided on a surface of the cutter or may befully or partially embedded within the cutter. In all such embodiments,the cutter may include a thermocouple to measure the temperature of thecutter and/or tissue. The electrode/heating element may be used tocoagulate the tissue, minimize bleeding/bruising, and/or to provide skintightening.

Referring back to FIG. 2A, cutting tool 102 may be configured to cut thefibrous septae 220 at the interface between the dermis and the fatlayer, within the shallow tissue layer 205 which applicant defines asthe layer 0-10 mm below the dermis, or, in the deep tissue layer 221defines as the layer 10-30 mm below the dermis, e.g., between thesubdermal fat layers and the skin 204, at depth 215. Previouslydescribed embodiments included a mechanical or motor-controlledbayonet-like device, RF cutter, a high-pressure injection system,needle-type injection, and the like. Turning now to FIG. 18, the cuttingtool 102 may also include an elongated thin hollow subdermalcatheter-like instrument 1801 having a retractable cutting blade 1802.

The term “subdermal catheter” is used herein to describe any elongatedobject which can be used to penetrate the skin or be placed through ahole in the skin, including, but not limited to, a hypodermic needle, acutting tool, a catheter, or other device that can puncture or be placedthrough the surface of the skin. The subdermal catheter is insertedthrough an incision (made by a sharpened distal end of the catheter orother cutting device) between 0.4 and 4 mm because to avoid or minimizeresidual scarring which are undesirable in a aesthetic procedure.Subdermal catheter 1801 can be rigid or flexible, and may be made of astainless steel alloy, metal, plastic, or any other material known inthe art.

The distal end 1803 of subdermal catheter 1801 is preferably configuredto be percutaneously inserted into a treatment area and to move withinthe treatment area in a manner substantially parallel to the surface ofthe skin. In some embodiments, distal end 1803 of subdermal catheter1801 may be honed, composed of a separate sharp tip such as a trocartip, or may be equipped with unbeveled blunt-tip. It may be placedthrough the skin with an introducer.

Retractable cutting blade 1802 includes one or more blade members 1804deployable from a collapsed position to an extended, lateral position.In some embodiments the one or more blade members 1804 are deployablefrom one or more sides of subdermal catheter 1801 at or near a distalend 1803. In this embodiment, cutting tool 102 preferably maintains anarrow profile, taking on the dimensions of a relatively large gaugeneedle, so that when blade members 1804 are fully collapsed it may bepercutaneously inserted into the subcutaneous level of tissue, in thesubdermal fat layer below the epidermis and dermis layers. Blade members1802 are preferably configured to remain substantially parallel to thesurface of the skin when in the extended position. Once deployed, theblade members 1802 can be used to shear fibrous septae 220 bymanipulating the device in a forward and backward motion parallel to theepidermis to create a dissection plane beneath the skin. The device hasbeen shown to especially useful in breaking up fibrous structures thatare oriented in a parallel fashion (and perpendicular to the skin).

In one embodiment, depicted by FIG. 19A, a single blade member 1901 ispivotably associated with cutting tool 102 at or near a distal end ofthe cutting tool such that when blade member 1901 is collapsed orretracted it is parallel to the device, and when it is deployed the endsof the blade member extend laterally away from the device. In anotherembodiment, as shown by FIG. 19B, a single blade member 1902 ispivotably connected at a proximal pivot point 1903 of the blade membersuch that the blade member 1902 foldably pivots from a closed positionwherein the unconnected (distal) end 1904 is proximate to, or inside,subdermal catheter 1801, to an open position wherein the unconnected end1904 of the blade member extends outward from the pivot point 1903.

In a further embodiment, as shown by FIG. 19C, the device includes twoblade members 1902 pivotably connected at an (proximal) end of eachblade member such that the blades foldably pivot from a closed positionwherein the unconnected (distal) ends 1904 are proximate to each other,to an open position wherein the unconnected ends 1904 extend outwardfrom pivot point 1903. In one aspect of this embodiment, the two blademembers 1902 are connected together at common pivot point 1903. Inanother aspect, the blade members 1902 may be connected at independentpivot points (each blade having its own pivot point 1903) attached to,or associated with, a common rigid member. As shown by the illustrativeembodiments the one or more blade members may be collapsed to and fromsubdermal catheter 1801 by way of an elongated opening 1906 on eachrespective side of the device.

In some embodiments, as depicted by FIG. 20, the blade members 1902 areassociated with a supporting structure 2001. Supporting structure 2001may include a hollow tube or may be a flat support surface on which theblade members are pivotably affixed. In some embodiments subdermalcatheter 1801 may comprise at least a portion of supporting structure2001. A deployment member 2002 may move inside subdermal catheter 1801and/or be associated with supporting structure 2001. In someembodiments, the pivot location of one or more blade members (comprisinga common pivot point or a common rigid member having multiple pivotpoints) is connected to, or associated with, supporting structure 2001and elongated deployment member 2002 for deploying the blades.Deployment member 2002 moves to release the blade from a constrainedposition, and may move to retract the blade members from a deployedposition. Deployment member 2002 is preferably rigid and can be made ofstainless steel, metal alloy, plastic, or any other similar material.The material of deployment member 2002 may also be non-rigid orsemi-rigid depending on the embodiment and the application of thedevice.

Because of the device's narrow profile and protracted cutting blades itis preferable to provide a maximum supporting force for each blademember against the internal lever force imposed on the blade memberswhen coming into contact with and/or cutting through the fibrous septae.Thus, two embodiments of mechanisms that provide efficient deploymentand support are explained for illustrative purposes.

With continued reference to FIG. 20, pivot location 1903 is fixed at apoint near or at the end of the device. A distal end 2003 of acollapsible support member 2004 is connected to a respective blademember at a location between its pivot point 1903 and distal end 1904 ofrespective blade members 1902. A proximal end 2005 of support member2004 is located proximal to device 102 and tracks parallel to the devicesuch that moving proximal end 2005 of the support member 2004 towardfixed pivot location 1903 applies an outward force 2006 on blade member1902 to move the blade member outwardly from the device.

In some aspects, deployment member 2002 may be associated with proximalend 2005 of support member 2004 from a location distal from pivotlocation 1903 to a location proximal to pivot location 1903. The supportmember may have a self-locking mechanism which selectively locks/unlocksthe support member in place once it has extended the blade member to thedesired location. The self-locking mechanism can be any means known inthe art. For example, the self-locking mechanism may lock and unlock bysudden force on the common joint of the support member as a result of anequal force placed on the deployment member.

As the support beam is collapsed, typically by moving deployment member2002 in a backwards direction, it acts on the blade member to move theblade member from a deployed position to a collapsed position. Inembodiments where there are two blade members, support member 2004 maybe comprised of two rigid members 2004 pivotably joined together at, andcollapsible from, a common center by a common joint 2005, and connectedto the respective blade members 1902 at the opposite ends 2003 of rigidmembers 2004. The proximal end of each rigid member 2004 is locatedproximal to the device and tracks parallel to the device such thatmoving center joint 2005 deploys or retracts each blade membersimultaneously in a manner similar to that described with one blademember. The two rigid members may lock into a straight rigid positionwhen fully deployed.

In another embodiment, each respective blade member may be deployedusing a channel and pin mechanism. A pin may be associated with theblade member near the pivot point. As the deployment member is movedfrom a proximal to distal position the pin associated with therespective blade moves within a respective channel disposed on asupporting structure. The channel may widen at the distal end to openthe blade member into a fully deployed position. In some aspects, thepivot location may also move proximally as the blade member opens anddistally as the blade member closes. In some aspects, one or more of thechannels may have a lock to secure the blade member via the pin when arespective blade member is in the deployed position. In other aspects,the subdermal catheter or other supporting structure may have a lockchannel at a distal end into which the blade member will snap into as itcompletes deployment. The lock channel may be on a bottom or a top ofthe supporting structure and the blade member and/or the pivot locationmay be driven into the lock channel by a spring or by the linearcurvature and/or resilient flexibility of the deployment member or anyother method known in the art. In some aspects, the deployment membermay have a locking mechanism to secure the deployment member inposition, and consequently secure the blades in either a retracted ordeployed position. The locking mechanism may be actuated from a controllocated at or near a proximal end of the cutting tool. In theseembodiments, support members 301, 306 may be optional.

The descriptions of the above support mechanisms are not intended to beexhaustive or to limit the invention to these precise forms of supportdisclosed. Other similar support mechanisms found to be technicallyuseful in micro-devices may also be constructed. For example, the bladesmay use a switchblade-like mechanism for quick deployment with acounter-lever for collapsing the blades, or an electric motor to movethe blades between a collapsed and extended position.

In some embodiments, for example, referring back to FIGS. 19A to 19C,the one or more blade members may be collapsed to and from the subdermalcatheter device by way of an elongated opening 1906 on each respectiveside of the device. Elongated opening 1906 may be narrow enough that theopening and closing mechanism (e.g., as illustrated in FIG. 20) andinternal area of the subdermal catheter 1801 are substantially protectedfrom the outside. Enclosing the blade members within subdermal catheter1801 during deployment enables the subdermal catheter to be inserted orwithdrawn from a patient minimally invasively. A thin membrane (notillustrated) may be disposed on either or both sides of the opening suchas to protect body fluids from entering into the subdermal catheter. Insome embodiments the aforementioned membranes may overlap each other toprovide better closure. The membrane can be made of any biocompatiblematerial known in the art, e.g., any of the non-absorbable polymericmaterials described above.

In some embodiments, the deployment member 2002 and the cutting blades1902 are deployable from inside the body the subdermal catheter 1801. Inthese embodiments the blades 1902 may be deployed from a collapsedposition from at or near the distal end 1803 of the subdermal catheter.In these embodiments, blades 1902 lie proximal each other inside hollowshaft 2001 and move to an outward position outside shaft 2001. Themechanics of blade members 1902 may be fully or partially exposed, thusnot requiring the elongated openings 1906 along the side of the device.In yet further embodiments the elongated openings 1906 are not required,or the device may have partial elongated openings along the side of thecutting device.

In some embodiments the blade members will collapse in a way that theywill substantially or completely overlap each other from end to end inthe collapsed position. In other embodiments, where the blade members1902 do not have the same pivot location, the blade members may collapsein a way that, when in the collapsed position, the blades are paralleland adjacent each other from end to end, e.g., as depicted in FIG. 21.The angle of deployment for each blade member may range between 0degrees in a fully collapsed position to 90 degrees in a fully deployedposition. Depending on the stability of the support beam or otherlocking mechanism it may be more preferable to allow a range between45-75 degrees so that the device can maintain a narrow profile duringdeployment, and to maintain maximum stability of the blades duringforward and reverse cutting action. Other angles, including an anglegreater than 90 degrees are possible depending on various factors,including the skin-type or fat-density of the patient to be treated.

In the illustrated embodiment, device 102 has a handle 1804 located ator near a proximal end of the device for control and positioning thedevice 102. The handle 1804 preferably includes at least one controlwire or rod for actuating the deployment and retraction of theretractable cutting blade 1802. The control wire extends through a lumenin the catheter from the handle 1804 to cutting blade 1802.

The device preferably has a deployment button or similar control 1805located at the proximal end of the device which actuates the controlwire and/or deployment member 2002 to move the blade members from adeployed and collapsed position. The deployment control may, forexample, include a control rod or wire which extends through a lumen ina catheter. The lumen supports the lateral sides of the control wirethereby enabling the wire to exert a pushing force without buckling.Pushing the deployment control 1805 may collapse the blades whilepulling the control may deploy the blades. In some embodiments pushingthe control may deploy the blades while pulling the control may collapsethe blades. In other embodiments pushing or pulling the control may doboth. In some embodiments the cutting device may have a handle or ahandpiece at a proximal end of the deployment member.

In some embodiments the device, including the subdermal catheter, willhave a round cross-section, while in other embodiments the device willmaintain a flat or oval profile. Generally, the cutting devicepreferably maintains a narrow profile such that it can be percutaneouslyinserted with minimal invasion to the treatment area. The nominal outerdiameter of the cutting device typically ranges from 0.5 mm to 3.5 mm(25 gauge to 10 gauge), but can be smaller or larger depending on thetolerance of the patient. Each of the embodiments disclosed hereininclude a cutting blade.

Generally, the cutting blades have a nominal width from about 0.5 mm to3.3 mm and a nominal thickness from about 0.1 mm to 0.8 mm, however, theblade can have a smaller or larger width and/or thickness depending onseveral factors, including the area to be treated or skin type. For thepurposes of illustration, the blade members are substantially flat.Other embodiments may include blade members that are curved, bowed, orangled, or any other design which could be useful in improving thecutting action.

In each of the embodiments described herein the cutting blade includes ashaft portion and a cutting portion where the shaft is defined as thatportion which does not contribute to the tissue cutting and the cuttingportion is the active and/or sharpened portion of the cutting blade. Thelength of the cutting blade may vary depending on the specificapplication and the material properties of the blade. Generally, thelonger the cutting blade the more difficult it is to prevent bending ordeflection (which is undesirable).

In each of the embodiments described herein the blades may have a sharpor a blunt edge to separate the fibrous septae. In some embodiments theblades are double sided thereby having an edge on each of the longersides. In other embodiments the blades are single sided. In someembodiments the distal and/or proximate ends may have a sharp edgeand/or may come to a point. For instance, the end proximal to the pivotlocation may be pointed such that the pointed end near the pivotlocation can be used as a spear to puncture the skin when inserting thedevice into a treatment area.

One or more of the blade members 1902 may be an RF electrode (monopolaror bipolar). If the blade members are RF electrodes they may beelectrically insulated from one another by providing an electricallynonconductive coating on portions of the blade members 1902.

The term cutting blade as used herein should be understood to include anRF electrode, harmonic scalpel or the like useful in cutting tissue in aminimally invasive manner. Thus the cutting blade may or may not includesharpened edges and/or a sharp tip. The term cutting blade may be asingle blade having one or more cutting surfaces and also encompassestwo or more blades. An RF electrode-cutting blade may be monopolar orbipolar such as such terms are commonly understood in the medical devicearts.

As depicted by FIGS. 21A and 21B, in some embodiments, subdermalcatheter 1801 may include an outer housing 2101 that is part of, orassociated with, the cutting tool and/or other blade mechanisms hereindescribed. In some aspects subdermal catheter 1801 may also include anouter housing 2101 that is part of, or associated with, a meshdeployment applicator (described below). Subdermal catheter 1801 may beused in conjunction with a handpiece 100. Moreover, the vacuum assistedhandpiece supports the cutting tool thereby facilitating a planardissection parallel to the dermis. In one embodiment, the crosssectional profile of the subdermal catheter is substantially flat so asto maintain a low profile when inserted between the skin and fat layers.In other embodiments the cross sectional profile of the subdermalcatheter may be round, square, triangular, hexagonal or any other shapeconfigured for the embodiments described herein.

In one embodiment, cutting device 102, is enclosed in a hollow shaft2101 which includes a hypodermic needle or skin penetrating means 2102located at the distal end of the shaft. Needle 2102 is sufficientlyrigid to allow skin perforation. In the illustrated embodiment the shaft2101 of hypodermic needle has a nominal inner diameter sufficient toenclose cutting tool 102, including the blades and their respectivedeployment mechanism. In some embodiments, hollow shaft 2101 includes atleast a portion of subdermal catheter 102. In one embodiment, asdepicted by FIG. 21B, the penetration means may include a sheath orslotted needle 2103 such that the end of the blades 2104 protrude from adistal end 2105 of the device and form at least a portion of thepenetrating means. Each blade may have a pointed proximal end such thatwhen the blade is collapsed the combination of blade members forms acutting edge 2106. In a further embodiments the retractable cuttingblade members may ride atop supporting structure 2103 near its distalend.

FIGS. 22A through 22E illustrate a further embodiment of cutting tool102 for creating a plane of dissection which cuts or resects the fibrousseptae. FIG. 22A depicts an embodiment of the cutting device including afluid injection port 2201 in fluid connection with a lumen 2202 in thesubdermal catheter. Fluid injection port 2201 may be used for injectinga treatment fluid such as an anesthetic and/or a vasoconstrictor intothe cutting area before, during, or after the tool is being used in thetreatment area. A thin tube may be disposed inside the subdermalcatheter (or a lumen may be defined in a wall of the catheter) alongwith the other mechanics of the cutting device. The thin tube (or lumen)can then be attached to a fitting at the proximal end of the subdermalcatheter for fluid connection with a syringe, syringe pump or otherinjection mechanism known in the art. In certain embodiments thetreatment fluid can be injected using the subdermal catheter. Thetreatment fluid may include a local anesthetic or pain relieving fluid,an antibiotic, or a combination of treatment fluids useful in similarmedical procedures. In some embodiments it may further be desirable tosubstitute port 2201 with an aspiration port operably connected to avacuum source to aspirate fluid and minimize the accumulation of fluid.

FIGS. 22B through 22D illustrate how the wire may be sharpened or formedto a blade. It is possible for blade 1802 to be made of a sharpened wire2203, where the wire diameter is from 0.5 mm to 3.3 mm and, as best seenin FIG. 22D becomes a non-circular cross-section after sharpening. FIGS.22B-22D show how the cross section of the wire changes from circular(FIG. 22B) to non-circular (FIGS. 22C and 22D) as the wire is sharpened.In some embodiments, the pre-sharpened wire may also have rectangularcross-section, and one or more of the edges of the rectangle may besharpened (not illustrated). FIG. 22A shows the wire implementation,where the wire is deployed to one side 2204 and exits proximal of thedistal end 2205 of cutting tool 102. Preferably, the location of wire2203 exit may range from distal end 2205 to about 3 cm proximal thedistal end of the catheter. In one embodiment, the sharpened aspect ofthe wire faces distal end 2205 of cutting device 102, and the cuttingfunction occurs when the device is pushed in the distal direction. In afurther embodiment, the sharpened aspect of the wire faces toward theproximal end, opposite distal end 2205, and the cutting function occurswhen the device is pulled back from the distal position. Optionally,both edges of the wire may be sharpened for cutting in either direction.Cutting wire 2203 may also be optionally gradually deployed in a seriesof cutting sweeps, where with each sweep the wire is deployed further toachieve a wide dissection plane. FIG. 22B represents a non-sharpenedportion of the wire, FIG. 22C represents a semi-sharpened portion, andFIG. 22D depicts a fully sharpened end for cutting when deployed fromdevice 102. Port 2201 may dispense for dispersing a fluid into thetreatment area or remove tissue from the treatment area as the device isused to cut fibrous structures and/or destroy adipose tissue.

Sharpened cutting wire 2203 may also form an RF cutter include an RF(radiofrequency) electrode connected to an RF amplifier (see FIG. 16B).As previously described embodiments, insulating coating may be appliedto the length of the electrode, leaving only a relatively small exposed(active) portion at or near the distal end of the wire. Wire 2203 may beused with or without activating the RF energy. Thus the RF may assist inthe cutting. RF energy may be supplied to wire 2203 in either a cuttingor coagulation mode as desired. It may be desirable to activate the RFenergy only after wire 2203 is positioned subdermally at the desireddepth to prevent or minimize injury to the skin. Moreover, the wireelectrode 2203 may be used to confirm resection by sweeping theunpowered wire electrode through the cutting plane. RF amplifier 1609supplies RF energy to the probe 2203 or any of the other RF probesdisclosed herein.

One method of using the present embodiments is directed to providing ahandpiece and cutting tools (described above) configured to minimallyinvasively create a plane of dissection. The handpiece and cutting toolsmay be suitable for cutting fibrous structures which may lie in theinterface between the dermis and the subcutaneous tissue. The handpieceof the present invention supports the cutting tool and enables the userto create a plane of dissection at a precisely defined depth and, ifdesired, inject or insert an implant into the treatment area. Ifdesired, the area of treatment may be injected with fluids comprisingbeneficial agents. It should be understood that any of the cuttingdevices disclosed in this disclosure may be used with any of theinjection and insertion methods and devices disclosed herein. The depthof the plane of dissection may be defined by the orthogonal distancefrom the tissue apposition (tissue facing) surface of the top wall tothe tool insertion conduit.

Throughout this disclosure the term mesh will be used to refer generallyto any generally planar foreign body sheet of material which isimplanted into subcutaneous tissue. The mesh may be composed of sutures,filaments, fibers, fibrous structures, scaffolding, quills or the like.The mesh used in any of the embodiment described herein may bebioabsorbable such that the mesh dissolves or is otherwise absorbed bythe body over time. Each of the embodiments disclosed herein may be usedto treat targeted areas, such as the upper leg below the buttocks wherecellulite is most visible.

The mesh may be implanted under the skin in order to promote increasedconnections between the skin and the fat and increase the durability ofthe reduced dimpling cellulitic appearance. In one embodiment the meshmay be made of any of a range of materials including but not limited topolypropylene, nylon, collagen, polymers of polyester, glycolide, orother suture materials. The mesh may either be absorbing ornon-absorbing. The thickness of the mesh can vary from 0.01 mm to 0.05mm and the area of the mesh may range from 1 mm to 100 mm. The mesh maybe formed in squares, circles, rectangles, or irregular shapes that arecustom cut to the patient needs.

In the embodiments disclosed herein it is preferred that the meshinclude a plurality of pores to promote the in-growth of tissue. Moreparticularly, the pores preferably have a pore size ranging from 50 μmto 5 mm such that it can become ingrown with tissue at that site toserve a useful therapeutic purpose. The pore size is patient dependent,and different pore sizes will be indicated for different patients. Thegoal pore size is as small as possible to create a smooth appearance anda maximum amount of fibrous attachment through the mesh; however, largeenough to promote rapid attachment of cells and maintain a highlyflexible and natural looking appearance.

In one embodiment, the implantable mesh is reticulated, such that it iscomprised of an interconnected network of pores, either by being formedhaving a reticulated structure and/or undergoing a reticulation process.This provides fluid permeability through the implantable mesh andpermits cellular in-growth and proliferation into the interior of theimplantable mesh. In further embodiments the mesh may include quills,sutures or other structures which bind into the surrounding tissue.

The mesh may be textured or treated on one side to promote binding toeither the skin or the fat side. The mesh may be textured or treated onboth sides to promote binding to both the skin side and the fat side.The treatment on the mesh may be a growth-promoting chemical toencourage rapid in-growth into the mesh from the body, and/orbiologically acceptable glue may be used to bind one or both sides ofthe mesh.

The mesh may be composed of stiff materials or flexible materials.Preferably, the mesh is highly flexible and easily contours to anycurvature. The mesh may be made of component material that is elastic ornon-elastic. In addition to being flexible, it may be desirable for themesh to be composed of elastic materials. Moreover, according to oneembodiment the mesh may be attached to tissue on both upper and lowerplanar sides (parallel to the dermis) thereof. Attachment of the meshmay be by way of adhesive glue or the like, sutures, staples, barbs,hooks or the like, In the case of non-elastic material, the mesh willlikely need to be bound on one side and free to move on the other side.Upon implantation, the mesh reduces dimpling by creating a substantiallyhigh density of attachments (new fibrous) between the skin and the fat,thus reducing the appearance of dimples and heterogeneity on the skinsurface. Over long term, e.g., 3-6 months after implantation, the meshpromotes more fibrous tissue which further reduces the appearance ofcellulite.

The implantable device may also include a biocompatible, reticulated(i.e. resembling or forming a net), resiliently compressible elastomericmaterial that is generally flat, flexible, and can recover its shape andmost of its size after compression. In some of these embodiments theelastomeric material may be comprised of a bioabsorbable polymericmaterial.

In some embodiments, the implantable device (frame and/or mesh) has aresilient compressibility that allows the implantable device to becompressed under ambient conditions, e.g. at 25° C., from a relaxedconfiguration to a first, compact configuration for in vivo delivery viaa delivery-device and to expand to a second, working configuration, insitu. The implantable device can be suitable for long-term implantationand having sufficient porosity to encourage cellular in-growth andproliferation, in vivo. Preferably, the implantable device isconstructed such that it may be encapsulated and ingrown within thetreatment area, and does not interfere with the function of the regrowncells and/or tissue, and has no tendency to migrate.

In some embodiments, the period of implantation will be at leastsufficient for cellular in-growth and proliferation to commence, forexample, in at least about 4-8 weeks. In these embodiments, the devicemay be sufficiently well characterized to be suitable for long-termimplantation by having been shown to have such chemical, physical and/orbiological properties as to provide a reasonable expectation ofbiodurability, meaning that the device will continue to exhibitbiodurability when implanted for extended periods of time, e.g. thedevice may include a biocompatible elastomer that may be consideredbiodurable for the life of a patient.

Furthermore, in certain implantation applications, it is anticipatedthat implantable device will become in the course of time, for example,in 2 weeks to 1 year, completely absorbed, encapsulated by tissue, scartissue or the like, or incorporated and totally integrated into, e.g.,the fibrous repaired. In some embodiments the implantable device iscompletely biocompatible such that the probabilities of biochemicaldegradation or release of undesired, possibly nocuous, products into thehost organism may be attenuated if not eliminated.

As shown by FIGS. 23A through 23E, the system may include a meshdeployment applicator 2301 to deploy a fibrous mesh 2302 through asingle needle hole in a dermis to create a highly fibrous layer directlyor through wound healing processes. The implantable mesh may beself-expandable, and is generally flat, flexible, and can recover itsshape and most of its size after compression. In other embodiments mesh2302 may be detachably coupled to a resiliently compressibleself-expandable frame (not illustrated). In a first embodiment,implantable mesh 2302 is preferably disposed at or near a distal end2303 of deployment applicator 2301. The applicator is insertedpercutaneously through the skin using a subdermal catheter such as thatdescribed above, or by itself through a hole in the skin, to deploy theimplantable mesh located at or near its distal end to a treatment areain the subdermal fat or in the layer between the subdermal fat and theskin. It should be noted that the mesh applicator may be combined in akit or a system with any of the dissection devices and/or thevacuum-assisted hand piece described herein. Specifically, the meshapplicator may be included with handpiece 100 to be deployed throughconduit 213. The dissection devices disclosed herein may be used tocreate a subdermal pocket sized to receive the mesh.

As depicted in FIGS. 23A through 23C, implantable mesh 2302 can befolded and/or stretched on a guide-wire (not illustrated) or on aninternal sheath 2304 (that may also harbor a guide wire) in order toattain a cross section narrow enough to be preloaded into a secondsheath 2305, this external second sheath includes a hollow portion 2306of deployment applicator 2301, or similar delivery catheter associatedwith deployment applicator 2301.

In one embodiment, depicted by FIGS. 23A through 23B, the implantabledevice may be folded onto internal sheath 2304 and disposed withinexternal sheath 2305, and is deployed when the device becomesunrestrained by external sheath 505.

In other embodiments, depicted by FIG. 23C, implantable device 2302 maybe rolled onto itself and disposed within external sheath 2305.Implantable device 2302 may be deployed by removal of the externalsheath 2305. For example, the apparatus may be deployed by pushinginternal sheath 2304 or guide wire in a distal direction 2307 out fromdevice 2301.

In some embodiments, deployment applicator 2301 may include arestraining member that is actuated by heat, electricity, or other meansknown in the art to release the mesh apparatus from its collapsed andrestrained position to its relaxed and expanded position.

In one embodiment external sheath 2305 may include the subdermalcatheter 1801 previously described or may be positioned within subdermalcatheter 1801 along with cutting blade members 1902. In this embodimentcutting tool 102 includes a hollow end depicted in FIG. 21A.

Preferably, the collapsed applicator has a sufficiently narrow profileto be threaded through deployment applicator 2301 or subdermal catheter,previously described. The applicator is preferably insertedpercutaneously through the incision made by cutting tool 102, or otherhole or incision in the skin created by the various dissection devicesdescribed herein. While applicator 2301 may be used with handpiece 100,applicator 2301 can be deployed through any needle hole in a dermis. Inone embodiment, the thickness of the implantable device when in acollapsed form, i.e., when folded, rolled, and/or stretched to beaccommodated by the applicator, has an outer diameter of from about 0.65mm to about 2.2 mm. Suitable delivery sheaths 2305 can have an outerdiameter from about 1 mm to about 3.3 mm. In other embodiments, theouter diameter of the deployed device or delivery sheaths can be greateror smaller depending on the configuration of the dissection needle.

As illustrated by FIG. 23E, mesh 2302 (with or without a correspondingframe (not shown)), when in a relaxed and expanded form, has a lengthand/or width 2307 typically in a range from about 1 cm to about 5 cm. Inother embodiments, the range may be up to 10 cm or higher depending onthe size and configuration of the deployment applicator and dissectionneedle. Mesh 2302 is depicted as substantially square, but can be anyshape suited to be placed in the subdermal fat or in the layer betweenthe subdermal fat and the skin. For instance, and without limitations,the fully expanded mesh can be circular, rectangular, triangular,hexagonal, or even irregularly shaped.

FIGS. 24A through 24F depict a second embodiment of a mesh deploymentapplicator. In this embodiment, a sheath 2305 may include or beinterchangeable with an introducer needle 2401, and a guide wire may beomitted. A deployment shaft 2402 and keeper rod 2403 are disposed insideintroducer needle 2401. Mesh 2404 is configured to be furled (i.e.,rolled up) around shaft 2402 and keeper rod 2403. Introducer needle 2401(with mesh inside) may then be inserted through an entry wound 2405created by tool 102. After insertion, needle 2401 slides off over aproximal end 2406 of shaft 2402 and keeper rod 2403, leaving the furledmesh 2404 positioned with subcision region 2407. Shaft 2402 issimultaneously rotated about its longitudinal axis 2408 to un-furl mesh2404, and pivoted about the skin-entry point 2405 to pull mesh 2404across subcision region 2407. Keeper rod 2403 is maintained in a fixedposition as mesh 2404 is un-furled, so as to anchor the edge of mesh2404 at the desired location within subcision region 2407. As shown byFIG. 24C, shaft 2402 pivots 2408 about skin-entry point 2405, aided bythe dissection handpiece 100 (discussed above). As mesh 2404 continuesto be un-furled, a greater portion of mesh 2404 is deployed acrosstreatment area 2407. FIG. 24E depicts mesh 2404 in a fully deployedposition. As depicted in FIG. 24F, after deployment, keeper rod 2403 andshaft 2402 can then be withdrawn through entry point 2405, leaving mesh2404 in the desired position within subcision region 2407. In oneembodiment, a longitudinal slit 2409 is present on a distal end 2410 ofshaft 2402 and keeper rod 2403. Mesh 2404 is secured when mesh 2404 iswrapped around shaft 2402 or keeper rod 2403, however, slits 2409 areopen on distal end 2410, so when shaft 2402 and rod 2403 are withdrawnas illustrated, mesh 2404 slips off the end of shaft 2402 and rod 2403.

With reference to FIG. 16B, in some embodiments the system includes anenergy device 1608. In accordance with these embodiments the insertabletool and/or handpiece may be configured to apply energy such as RF,ultrasound, or microwave energy to the tissue before or after the meshhas been inserted into the treatment area. Although not specificallyillustrated, it should be understood that an appropriate energy source1609 (ultrasound amplifier, RF amplifier, microwave) will need to beoperably connected to handpiece 100. In some embodiments energy source1608 may be used to create damage sites along the mesh that will heal asfibrous structures, and/or to shrink the mesh and create a tightening ofthe subcutaneous tissues. Energy device 1608 may include a microwave,conductive heat, ultrasound, or RF. In some embodiments the energy mayalso be applied to shrink the self-expanding implantable device after ithas been deployed under the skin.

With reference to FIGS. 9B and 9C, a physician first applies a referencemark 904 to the dermis to identify an area for treatment, and handpiece100 is positioned on an outer portion of the skin 903 to be treated.Handpiece 100, including transparent cover 206, is subsequently placedover mark 904 on dermis 903 and a vacuum is applied. Mark 904 is thensuctioned against the upper tissue apposition surface 203 such that mark904 on dermis 902 is visible through the clear top portion 206 ofhandpiece 100. A reference feature 905 on handpiece 100 indicates theregion that dissection will occur, and the physician verifies that mark904 falls within the dissection region 902. FIG. 9C depicts handpiece100 used in conjunction with a NOKOR™-like subcision device capable ofcutting septae and infusing a tumescent fluid, however, any cuttingfeature or device disclosed above may be used with this embodiment.

An embodiment of using the device includes percutaneously inserting acutting tool through the epidermis of the skin and into the subcutaneoustissue layer or in the layer between the subcutaneous tissue and theskin.

(1) A first step, depicted by FIGS. 1A and 1B, includes capturing thetissue to be treated into the recessed portion of the handpiece. In someembodiments this entails applying a manual pressure or force on thehandpiece. In other embodiments this entails using a vacuum enabledhandpiece to bring the tissue into contact with the recessed portion ofthe tissue apposition surface. Suction from a remote vacuum source 1606(FIG. 16B) is supplied to one or more ports 208 (FIG. 2) in thehandpiece to pull the tissue into a recess bounded on top and sidesurfaces. Precise depth control, where depth is measured orthogonallydownward (into the tissue) from the dermis is believed to be animportant factor in achieving consistent and uniform results. In otherwords, it is important to create a planar lesion at a fixed depth belowthe dermis. FIG. 2 depicts a portion of subcutaneous tissue 205 disposedwithin the recessed area of the handpiece.

(2) A deployable tool (102, 303, 1001, 2401) is then placed into andthrough the conduit in a side of the handpiece, such that the tool isplaced in a precise tissue depth in the subcutaneous tissue or in thelayer between the subcutaneous tissue and the skin. The tool may have acollapsible blade or may pierce the skin like a bayonet. In oneembodiment the tool may be any cutting tool as described in previousparagraphs. In another embodiment the tool may be a hypodermic needlefor anesthetic fluid administration. In another embodiment the tool maybe a specialized larger diameter hypodermic needle, or subdermalcatheter, configured to allow deployment of a cutting tool and/or otherdeployment devices through its center.

(3) Once in place, the cutting tool is actuated. In some embodiments,actuation of the cutting tool entails deployment of the cutting blades.In some embodiments, the cutting blade is simply inserted percutaneouslythrough the dermis at a desired depth. In some embodiments, the cuttingtoll is an RF needle. The RF needle may be provided with a sharp tip forpenetrating the dermis. In some embodiments, the tip may be blunt orbeveled. Actuation of the RF needle entails supplying RF frequencycurrent from an RF amplifier to the needle in either a cutting mode orin coagulation mode. To avoid damaging the dermis, it is desirable tosupply the minimum amount of energy during cutting to avoid or minimizeheating of the dermis.

Optionally, one or more cutting blades of the cutting tools are thendeployed from the cutting tool. In one embodiment, deploying the cuttingblades include actuating a control at a proximal end of the tool. Thecontrol may be actuated by a simple switch, lever, or control rod whichis either pulled, turned or pushed to control actuation of the cuttingblades. In some of the embodiments the cutting tool is not collapsedthus the un-collapsed cutting blade is percutaneously inserted and thereis no need to deploy the cutting tool.

(4) The tool is then manipulated to create a dissection plane and sever,where necessary, fibrous structures 220 (FIG. 2) between the skin andthe subcutaneous tissue at a precisely defined depth maintained by thehandpiece and tissue apposition surface. In one embodiment the tool cutson the reverse stroke as it is pulled back (retracted) 227 to severfibrous structures 220. In another embodiment, the tool cuts on theforward stroke as the tool is deployed and pushed forward 228 to severthe fibrous structures. In a further embodiment the cutting tool isoptionally moved in a forward and reverse direction, i.e. reciprocated.In a further embodiment conduit 213 is configured to provide someside-to-side movement parallel to the surface of the skin (FIG. 2B). Inother words, the conduit is somewhat larger gauge than the cutting tool,thereby enabling the cutting tool to be pivoted in an arc fromside-to-side. In a yet further embodiment advancement and sweeping ofthe tool during cutting is microprocessor controlled.

(5) After completion of the dissection and cutting of the fibrousseptae, the tool is collapsed and/or removed from the tissue and thehandpiece. Optionally, the cutting blades are then retracted by any ofthe means described for deploying the blades. Or as described above, insome embodiments there is no step of deploying or underdeploying theblade. In one embodiment the blades are retracted by moving the actuatorin the opposite direction as it was moved to deploy the blades. Inanother embodiment the blades are retracted by moving the actuator inthe same direction. As noted previously, some of the cutting tools maynot utilize collapsing cutting blades in which case the cutting tool issimply withdrawn. Optionally, the users may sweep the cutting tool toverify a clean dissection of the fibrous structures. If resistance isencountered when sweeping the cutting tool then steps 4 and 5 may berepeated.

In some embodiments, a treatment fluid may be injected into the cuttingarea at or between any step of cutting inside the tissue. The fluid maybe actively injected, for instance by using a syringe, or may be drawninto the pocket from an external reservoir by the reduced pressurecreated by a vacuum applied to the handpiece. The fluid may perform anumber of functions, as described above in paragraph 00110.

The treatment fluid may also be injected prior or after deployment ofthe blades and/or cutting steps. If the cutting tool includes theapplication of energy the treatment fluid may be selected to enhance thedelivery of energy. For example, if the cutting tool is an RF electrode,the treatment fluid may include saline or like conductive fluid toprevent charring of the tissue. It may be desirable to control suchenergy based on the measurement of an applicable parameter such astissue impedance or temperature. As someone with ordinary skill in theart would realize, such feedback control would be comprised of amicroprocessor based algorithm. As used throughout this disclosure, anyreference to applying energy should be understood to define theapplication of one of radiofrequency (RF), ultrasound, microwave, orthermal energy.

As in previous embodiments, and as depicted by FIGS. 26A and 26B, andwith further reference to FIG. 10A, a treatment fluid may be insertedprior to or after the dissection process. Injection device 1004 isinserted into the guide track 302 preferably at entry point 1008. Thetissue to be treated is disposed in recessed area 105 as previouslydescribed. Needle 1001 may then be easily guided through conduit 213 andentry hole 214 and into the tissue by moving injection device 1004 alongany of radial tracks 1005 toward handpiece 100. For example, injectiondevice 1004 is first moved down the central channel in a forwarddirection 2601 to directly insert needle 1001 into the tissue. Thetreatment fluid is then injected using needle 1001 manually usingsyringe 1003 or, in some embodiments, by a microprocessor driveninjection pump (e.g., FIG. 15). After the fluid is injected needle 1001is removed by reversing direction along track 1005. Injection device maythen be rotatively moved in an arc 2602 along cross-track 1007 to bepositioned in an alternate radial track 1005. Injection device 1004 isthen moved a second time down radial track 1005 in a forward direction2603 to insert needle 1001 into a further location within the treatmentarea. Needle 1001 passes through the same entry point 214 while thewidened shape of conduit 213 allows repositioning of needle 1001 withrespect to rotational angle 2602 and radial tracks 1005. The process maythen be again repeated for the third track 1005, or as many times as isdetermined to be necessary by the treating physician. In someembodiments, needle 1001 is a 22 gauge multi-holed, single-use needle.Needle 1001 includes multiple holes along its sides so as to, once it isfully inserted, saturate the tissue along its injection path. Injectingthe fluid along the paths set by the disclosed injection guidance track,thus allows a fluid, such as an anesthetic and/or a vasoconstrictor, tofully saturate the treatment area while providing precise needleguidance and specific depth. It has been found that the method reducesthe number of needle sticks necessary to infuse the area to be treated,increases anesthesia effectiveness, and substantially minimizes pain.Because the handpiece remains in the same position between fluidinjection and dissection (subcision) locality of anesthesia relative todissection is assured, and the swappable guidance track provides rapidswitching between medicament delivery and dissection and vice versa soas to increase fluid retention throughout the process. Furthermore, themodularity of the platform and guidance track ensures that the processis repeatable and scalable.

The device allows for three-dimensional control of treatment fluiddelivery and dissection of subcutaneous tissues, not realized by presentart. The device typically controls a depth of between 4 mm and 20 mmbelow the surface of skin; however, a depth lower than 4 mm or greaterthan 20 mm is contemplated. The range of motion in the lateral directionis controlled by the effective length of the needle or blade or othercutting device, however, typically encompasses an area of between 2 mmand 50 mm in either direction. As the cutting device is disposed furtherinto the subcutaneous space larger areas are achievable.

It is generally recognized that a large treatment site heals more slowlythan a series of smaller treatment sites. Moreover, the larger thetreatment site the greater the risk of seromas, uneven healing,fibrosis, and even skin necrosis. Turning to FIGS. 27A through 27D, thisproblem is addressed, in one embodiment, by utilizing a adjustable depthfeature (e.g., FIGS. 12, 13, 14). Each treatment site 2701 is an islandsurrounded by tissue 2702 which has not been treated (the fibrous septaehave not been severed at the same plane). As depicted by FIG. 27A,handpiece 100 is used to treat a first treatment area 2701. In someembodiments, after the tissue within the first treatment site istreated, the handpiece can be repositioned on a different treatment area2701 at the same, or at a different or alternating depth as, forexample, in a checkerboard fashion.

According to further embodiments, a relatively large treatment area isdivided into a plurality of smaller treatment sites. FIGS. 27B and 27Cshow two or more treatment sites 2701 a, 2701 b, 2701 c surrounded byuntreated tissue 2702. In some embodiments, the spacing in the X-Y plane(parallel to the dermis) between adjacent treatment sites is reduced oreliminated. In some embodiments, the treatment sites could even overlap.Zero spacing (or overlapping) between adjacent sites is possible ifadjacent treatment sites are at different treatment depths (measuredperpendicularly from the dermis) and the bridge of untreated tissue canbe greatly diminished without impacting the tissue healing time. In theembodiment depicted by FIG. 27C, treatment sites 2701 a and 2701 c areat a different treatment depth than 2701 b. According to a furtherembodiment, treatment sites may not be contiguous, meaning that thereare no multiple connected lesions. For instance, a further treatmentarea may include unconnected treatment sites 2703.

According to yet another aspect of the invention, adjacent treatmentsites 2701 touch or even overlap but are at different treatment depths(measured in a direction perpendicular from the dermis). Thus, from atop view (FIG. 27C) the plurality of treatment zones 2701 a, 2701 b,2701 c appear to be continuous, but from a side view, depicted by FIG.27D, it is clear that the “checkerboard” lesions 2701 a, 2701 b, 2701 care at different treatment depths. In other words, adjacent sites are atdifferent treatment depths.

The interspersing of treatment sites at different treatment depths isbelieved to accommodate rapid healing. More specifically, theinterspersing of treatment sites at different treatment depths allowsfor closer spacing between treatment sites while accommodating for amore rapid healing response time of the injured tissue. As the treatmentarea(s) heal, the tissue in the treated subcutaneous area regrows withminimal adipose tissue and minimal thickness such as to alleviate andsubstantially reduce the appearance of cellulite. According to yetanother aspect of the invention, the benefits realized by the multipledepth treatment enabled by the embodiments may be based on the severityof the specific lesion(s) or the specific area on the body beingtreated. For instance, it may be desirable to treat a deeper lesion at adeeper depth. Dimples or lesions on the thighs, for example, may betreated at a different depth than lesions on the buttocks. According toyet another aspect of the invention, the size of the dissection may alsobe adjusted by incomplete or partial movement of the cutting meanswithin the guidance track. For example, with reference to FIGS. 6A and6B, a smaller area may be treated than the total area accessible byguidance track 302 by not completing movement of the cutting modulethroughout all the arcs 602 or by not moving laterally as far along thearcs.

Methods according to the invention may be used to perform subcutaneoussurgery in a minimally invasive manner. Steps comprised in exemplarymethods of the invention to create a subcutaneous lesion areschematically outlined in the flowchart of FIG. 28B. Briefly, a sectionof skin and underlying tissue to be treated is anesthetized.Alternatively, general anesthesia may be employed. Next, a handpiecewith a recessed area according to the invention is positioned over thesection of skin. The air pressure inside the recessed area of thehandpiece is reduced to lift the skin and the underlying tissue into therecessed area. The depth of the handpiece may be set at a level thatallows the tissue plane to be dissected to align with a tool conduit inthe handpiece. A lesion creation tool is inserted, and a lesion created,typically by moving the lesion creation tool along a guidance track.After completion of the lesion, the lesion creation tool is removed, thereduced air pressure returned to ambient, and the handpiece removed.Commonly created lesion types include dissections and thermal andchemical ablations. A number of different lesion creation tools may beused in methods according to the invention, and may be selected based onthe type of lesion desired. For instance, to achieve a dissection ablade, needle or cutting wire may be employed. Also, cauterization,radio frequency, laser and water jet probes may be used in a cuttingmode. Alternatively, if tissue ablation rather than dissection isdesired, ultrasound probes, radiofrequency probes, laser probes, steamablation probes, or other thermal probes may be used in a tissueablation mode, thus thermally ablating the target tissue. Chemicalablation may be achieved by infusing sclerosants like ethanol,hypertonic salt or surfactant solutions. An RF or other type of energytool can be used to coagulate and cut tissue at the same time with thesame tool.

As described in more detail below, the reduced air pressure appliedduring the procedure may aid in creating an effective lesion, especiallya dissection, possibly through the tension it puts on the tissue. As anoptional step, as illustrated in FIG. 28C, the reduced air pressure maybe maintained after completion of the lesion, for a period of timedetermined by the physician performing the procedure.

Previously, the use of increased rather than reduced pressure whilecreating a subcutaneous lesion has been described in the art, forinstance by pressure infusion of an anesthetic solution during tumescentanesthesia. This increased pressure has been used to achieve morecomplete separation of the tissue layers surrounding a dissection plane.

It has now been observed that applying reduced pressure while creatingthe subcutaneous lesion, and optionally, maintaining the reducedpressure, for a period of time to be determined by the physicianperforming the procedure after completing the lesion, resulted inimproved and more durable outcomes of the procedures. While themechanism for this improved efficacy is not known with certainty,without being bound by theory, it is possible that the reduced pressuretransmitted to the lesion enhances the tissue separation by forcingendogenous fluids, like blood and other extracellular fluids, toinfiltrate into the lesion, thus creating an enlarged subcutaneouspocket. The presence of the endogenous fluids, and the formation ofthrombus from the clotting of blood in this subcutaneous pocket, mayhave beneficial effects on the ensuing wound healing process.

Also, as will be discussed in detail below, a common feature of manysubcutaneous tissues in humans is the presence of fibrous septae,connecting the skin to a subcutaneous tissue layer. Methods according tothe invention include severing such fibrous septae. Applying reduced airpressure to the skin overlying the tissue and intended lesion may puttension on these septae, allowing for a more efficient severing process,as well as for an instantaneous and effective separation of the severedends of the septae, preventing possible re-attachment and regrowth.Additionally, any fibrous septae that are not naturally orientedperpendicular to the skin and the plane of the dissection may be forcedinto a more perpendicular orientation by the force exerted on the skinfrom the reduced pressure, again allowing for a more efficient severingprocess.

Optionally, the procedures of FIGS. 28B and 28C may be repeated on anadjacent or overlapping section of skin.

Some methods disclosed herein may be especially useful in theperformance of therapeutic or cosmetic procedures directed at improvingthe appearance of skin features. In particular, methods of the inventionmay be used to improve the appearance of deformities in sections ofskin, for instance deformities such as scars, a wrinkles, and surfaceirregularities resulting from liposuction. The appearance of suchdeformities can be improved in various ways, including reducingdifferences in elevation between such deformities and the surroundingskin, making the tissue surface more uniform in texture, smoothness,color, and/or elevation within and/or around a deformity, redistributingfat or other tissue underlying a deformity to create a more smooth anduniform appearance, reducing tension or the appearance of tension withina deformity or between the deformity and surrounding skin, and othersways. Human skin is frequently attached to underlying layers ofsubcutaneous tissue by fibrous septae, limiting the mobility of the skinwith respect to the underlying tissues. Such fibrous septae are oftendetrimental to the efficacy of corrective surgical procedures, such ascosmetic surgery, the prevention of hypertrophic scars after injury, andimplantation procedures for cosmetic or therapeutic substances. Anexample of such fibrous septae is illustrated in FIG. 29 for theattachment of atrophic scars to underlying tissue. As is illustrated inFIG. 30A-30D, and as will be discussed in more detail below, preferredmethods of the present invention allow for an efficient and minimallyinvasive severing of such fibrous septae, enabling more effectiveimprovement of the skin features, and, where desired, introduction oftherapeutically or cosmetically beneficial substances.

It should be understood that, although the detailed description below,and as illustrated in FIG. 30A-30D is specific to the treatment ofatrophic scars, in particular acne scars, the procedure isrepresentative of other methods and treatments generally falling withinthe scope of the invention.

In some embodiments of the invention, methods to perform subcutaneoussurgery are directed at treating atrophic scars, including acne scars.As illustrated in FIG. 29, atrophic scars are characterized by a sunkenrecess morphology of the epidermis 2904 and the dermis 2905. Severalsub-types of acne scars have been described in the literature, and theiretiology and patho-physiology are broadly representative of most typesof atrophic scars. Other commonly occurring types of atrophic scars arethose secondary to chicken pox, skin infections or accidental orsurgical trauma.

A common classification divides atrophic acne scars in three groups:

Ice pick scars 2901, with steep walls and a pitted appearance;

Boxcar scars 2902, with steep walls and a more or less defined bottom;and

Rolling scars 2903, typically showing a more gradual depression.

Rolling scar tissue is further characterized by the fact that it istethered to the underlying subcutaneous tissue 2906 by fibrous septae2907.

A surgical treatment sometimes used for the treatment of atrophic scarsis subcision, in which a tri-beveled needle is repeatedly inserted intothe subcutaneous space to cut subcutaneous tissue, specifically thefibrous septae. In a typical procedure the needle may be inserted manytimes, moving in fan-shape patterns radiating from its access site. Thismay be followed by a fan-like sweeping action, to ensure full detachmentof the tissue layers. This procedure makes the method time consuming andprone to inadvertent deeper injury due to the large number of lancingmovements with the needle.

Additionally, in clinical practice, re-depression after an initiallyseemingly successful procedure is commonly observed. It is thought thatinitially blood and extracellular fluid fill a pocket around thedissected needle tracks that provides lift to the treated scar. When aninadequate pocket is created, resorption of the coagulated blood andfluids over time may cause the pocket to collapse, causing the latefailure.

Achieving a complete dissection plane with reliable severance of allfibrous septae and the creation of an adequate tissue pocket to providesupport to the overlying scars after complete healing are considered keyfactors in the achievement of durable results.

Furthermore, local application of reduced air pressure over individualsubcised acne scars has been reported to reduce the incidence ofre-depression. In some instances, periodically repeating the applicationof reduced air pressure over a period of up to two weeks has beenreported to be beneficial.

In an exemplary embodiment of the method, illustrated in FIGS. 28B and28C, and FIGS. 30A and 30B, creation of a dissection plane, severing ofthe and application of reduced air pressure to create an adequate tissuepocket are performed using a device according to the invention.

As outlined in the flow chart shown in FIGS. 28B-D, the skin area to betreated is first anesthetized.

Next, as further illustrated in FIG. 30A, a handpiece 3001 with arecessed area, having a vacuum conduit 3002 and a tool conduit 3003 isplaced on top of the epidermis 3004. The handpiece 3001 covers a boxcarscar 3006 and a rolling scar 3007. The tissue of the rolling scar 3007is attached to the subcutaneous tissue layer 3008 by the fibrous septae3009 through the dermis 3010.

As illustrated in FIG. 30B, a vacuum is then applied through conduit3002, pulling the skin area into the recessed area of the handpiece3001. A dissection tool 3011 is then inserted through the tool conduit3003 into the subcutaneous tissue underlying the acne scars and adissection plane 3012 is created, severing the fibrous septae 3009. Thedissection tool 3011 is then removed.

In a subsequent step, illustrated in FIG. 30C, a tissue pocket 3013surrounding the dissection plane 3012 is filled with fluid. The fluidmay be actively injected, for instance through tool conduit 3003. Thefluid may perform a number of functions, including mechanical supportand pharmaceutical activity, as will be described in detail below.Alternatively, endogenous fluids, like blood and extracellular fluidsmay be allowed to infiltrate the pocket 3013.

Finally, the vacuum is released, the handpiece 3001 removed, and, asillustrated in FIG. 30D, the skin area allowed to assume itspost-procedural position, in which the support provided by the fluids inthe subcutaneous pocket 3013 may lift the remnants of acne scars 3006and 3007 closer to the surrounding skin level.

As illustrated in FIG. 31 a guidance track 3101 matching the skin areato be treated may be used in addition to the handpiece 3102 at thediscretion of the physician.

It should be understood that the method outlined in the flow chart ofFIGS. 28B and 28C and illustrated in FIGS. 30A-30E is an example of manyvariations on the procedure falling under the scope of the presentinvention that can be performed at the discretion of the physician. Forinstance, the physician may decide to release the vacuum beforeinjecting a fluid into the dissection pocket. Alternatively, thephysician may decide that pulling vacuum in the skin and creating thedissection plane sufficiently releases the overlying skin, and omit thestep of actively filling the tissue pocket with fluid.

Also, the procedure may be performed in a single pass with a relativelylarge handpiece, or may be performed in a repeated sequence, in which asmaller handpiece is used multiple times on adjacent or overlapping skinareas. For instance, a physician may decide to use the methodexclusively for the severing of septae connecting individual rollingscars to the underlying tissue layer.

In some embodiments of the invention, methods to perform subcutaneouscorrective surgery are directed at treating wrinkles. As illustrated inFIG. 32A, skin tissue at the site of wrinkles, and especially facialwrinkles 3201 near the eye, may have extensive fibrous septae 3202connecting them to the underlying Superficial Muscular AponeuroticSystem (SMAS) 3203. Many cosmetic surgery procedures employ fillers,like collagen or hyaluronic acid to bulk up the space below the skin.This approach by itself often results in unsatisfactory results, becauseof the fixed attachment of the skin to the underlying SMAS 3203. Inthese cases, controlled severing of the fibrous septae 3202 may allowfor a more effective use of the fillers to reduce the appearance ofexpression lines. Severing fibrous septae 3202 can be performed by themethod and apparatus disclosed in FIGS. 28B-31.

Some embodiments of methods of the invention are particularly useful toimprove such corrective procedures. The steps in these methods areanalogous to the steps outlined in the flow charts of FIGS. 28B and 28Cand in the procedure of FIGS. 30A-30B for the treatment of atrophicscars. As illustrated in FIG. 32B for treatment of crow's feet 3201(skin wrinkles near the eye), a handpiece 3206 for applying vacuumadvantageously comprises a recessed area 3204 matching the fan-shapedpattern of the crow's feet 3201, and can be combined with a matchingguidance track 3207.

As illustrated in FIG. 33, an alternative embodiment of the inventionmay be used to treat wrinkles knows as laughing lines 3301 (skinwrinkles near the mouth). In this embodiment, a more elongated shape forthe handpiece 3302 and the guidance track 3303 are preferred, allowingfor a motion of a cutting tool matching the contours of the laughingline 3301.

As with the methods described above for the treatment of atrophic scars,many variations of the procedure, available at the discretion of thephysician, fall under the scope of the invention. For instance, thephysician may decide to insert an implant according to the methoddescribed below, rather than to inject a fluid.

In some embodiments of the invention, methods to perform subcutaneoussurgery are directed at treating sections of skin overlying tissue thathas been previously treated with liposuction. Liposuction proceduresfrequently remove considerable amounts of fat, and a successful outcomeoften relies on a redistribution of the remaining fat and on adaptationof other subcutaneous tissues into a smooth body contour, often by aidedby application of pressure and post-surgical massage. Insufficientmobility of the fat and subcutaneous tissue may result in an uneven andcosmetically unappealing appearance of the skin. In some of these cases,secondary procedures, sometimes referred to an autologous lipografting,are performed, in which quantities of fat are harvested from sites withexcess fat and reintroduced to sites that are in need of augmentation.Similarly to primary liposuction, insufficient mobility of skin andsubcutaneous tissue interferes with such procedures.

Major fat deposits frequently comprise substantial internal anatomicalstructures, often with a Superficial Adipose Tissue (SAT) layer and DeepAdipose Tissue (DAT) layer, separated by a more or less developedfibrous membrane. Extensive fibrous septae often exist in the SAT,between the skin and the fibrous membrane, mostly in a perpendicularorientation to the skin. The presence of these septae, in combinationwith the deposition of excess fat, is one of the underlying causes ofcellulite in women. Fibrous septae are found in the DAT as well,connecting the fibrous membrane to deeper fasciae, albeit less abundantthan in the SAT, and often in a more oblique orientation. The presenceof this network of fibrous septae tethering various cutaneous andsubcutaneous layers may impair the mobility of local tissues and preventthe creation of a smooth body contour. Additionally, trauma caused bythe probes used during the procedure occasionally leads to a scar-likehealing reaction involving the development of post-surgical subcutaneousadhesions, for instance between the dermis and the underlying fibrousmembrane. These adhesions may further impair skin and tissue mobility,and exacerbate the undesirable appearance of the skin.

Methods according to the invention may be particularly suitable forcarefully targeted severing of fibrous septae and adhesions atpre-defined depths with respect to the skin. For instance, severing thefibrous septae in the SAT can be achieved by lifting subcutaneous tissueinto a recessed area of a handpiece according to the invention, asdescribed in U.S. Pat. No. 8,518,069, which is incorporated hereby inits entirety.

An exemplary method to sever deeper located fibrous septae isillustrated in FIG. 34A. Epidermis 3401 and dermis 3402 overlie a SATlayer 3403 of fat. Fibrous septae 3404 connect the dermis 3402 to thefibrous membrane 3405. SAT layer 3403 has a satisfactorily evendistribution of fat, and disturbing the septae 3404 may actually have adetrimental effect, for instance by causing a loss of skin tone in theepidermis 3401 and dermis 3402. Fibrous membrane 3405 is connected to adeeper fascia 3406 by fibrous septae 3407. The fibrous septae 3407divide the DAT layer 3408 into compartments 3409, 3410 and 3411.Compartment 3410 has been successfully depleted of fat cells byliposuction, while compartments 3409 and 3411 still contain major fatdeposits. The fibrous septae 3407 prevent a more even distribution offat cells between the compartments 3409, 3410 and 3411.

Current treatments often used subcision techniques, in which sharpcanulae with an inverted V-tip, like the V-tip Toledo Canula, areinserted at a shallow angle through the various tissue layers to dissectthe septae 3407. The poorly guided direction and repeated lancing actionof these canulae has the potential for unwanted collateral tissuedamage.

Methods of the current invention, as outlined in FIGS. 28B and 28C, andas described in more detail in FIGS. 30A-30B, allow for a precise depthcontrol of lifting the skin and subcutaneous tissue into a recessed areaof a handpiece according to the invention. Subcutaneous fibrousmembranes and fibrous septae are detectable by ultrasound, and, ifnecessary, by CT imaging. These imaging techniques allow for a preciselifting of the tissue, and positioning of a plane of dissection at thelevel of arrow 3412, to be created through the septae, to align with atool conduit in the handpiece. As shown in FIG. 34B, the section of skinand the underlying tissue can be lifted into a recessed area 3413 of ahandpiece according to the invention, such that epidermis 3401, dermis3402 and SAT fat layer 3403 are precisely brought into apposition withthe top 3414 of the recessed area 3413. The depth of the recessed area3413 has been calibrated, based on previously mentioned imagingtechniques, to align a plane of dissection 3415, comprising the septae3407, to align with a dissection tool conduit 3416 in the handpiece. Inthis manner, methods according to the invention allow for precisetargeting of culprit fibrous septae, with minimal collateral damage tosurrounding and possibly beneficial anatomical structures.

In some embodiments of the invention, methods to perform subcutaneouscorrective surgery are directed at promoting wound healing and reducingthe occurrence and severity of contractile scars. Contractile scarformation is a serious and sometimes debilitating side effect of woundhealing. Tension within the plane of the skin at the site of the woundis generally considered a significant factor in the development ofcontractile scarring.

As illustrated in FIG. 35A, the placement of a suture 3501 over wound3502 may exert forces on the epidermis 3503 and the dermis 3504. Thenon-elastic fibrous septae 3506 anchor the dermis 3504 and epidermis3503 to the non-elastic subcutaneous tissue layer 3505, causing a highlylocalized tension, indicated by line 3507, at the site of the closedwound 3502, essentially creating a local stress riser. The skin itselftends to be more elastic than the fibrous septae 3506 connecting it tothe underlying tissue 3505. Severing the inelastic fibrous septae 3506at the level 3508 and creating a dissection plane 3509 shown in FIG. 35Brelieves the local stress by spreading the tension over a significantlywider area, as indicated by line 3510.

Embodiments disclosed herein may be used advantageously to perform thepost-wound closure procedure by following the procedure outlined in theflow chart of FIGS. 28B and 28C, and illustrated in FIGS. 30A-30B. Inthis case the handpiece is placed over a skin area that surrounds theclosed wound 3502 and the skin area with the closed wound isvacuum-pulled into the recessed area of the handpiece. Creation of thedissection is then performed as described above in connection with FIG.30B. Injection of fluids as described above to create additionalsubcutaneous space may be performed at the discretion of the physician.

In some embodiments of the invention, methods to perform subcutaneouscorrective surgery are directed at inhibiting hyperhidrosis.Hyperhidrosis is a condition characterized by an excessive production ofsweat by eccrine sweat glands, specifically in the armpits, hands andfeet. As illustrated in FIG. 36A, sweat glands 3601 lie in a relativelynarrow band of depth underneath the dermis 3602 and secrete sweatthrough the sweat duct 3603 to the epidermis 3604. Sweat glands can bedetected by ultrasound. Sweat glands 3601 are innervated by branches3605 of the sympathetic nerve system.

Two different approaches to treat hyperhidrosis are available formethods according to the invention. One approach involves obliterationof the sweat glands 3601 by the creation of dissection plane 3607through the glands 3601 themselves, effectively destroying them. In thiscase, a handpiece is placed over an area of skin containing sweat glandsto be obliterated, and the depth of the recessed area is set such that,after application of reduced air pressure, the sweat glands 3601 arepositioned at the level of the tool conduit, facilitating the creationof a dissection plane. The dissection plane 3607 is created at the levelof arrow 3606, effectively cutting through the sweat glands 3601. Thedissection can be performed with a mechanical dissection tool, like aneedle or a blade, or with a heat-enabled cutting tool like an RF probe.

The use of an RF probe may be particularly effective in that the energyoutput can be chosen to create an area of tissue destruction beyond theimmediate dissection plane, allowing obliteration of sweat glands that,because anatomical variability, fall outside the actual dissectionplane.

The second approach is directed at denervation of the sweat glands 3601by severing the sympathetic nerve branches 3605 activating the glands.The nerve branches 3605 approach the glands 3601 from below, asillustrated in FIG. 36B. In this approach the, tissue is pulled slightlydeeper into the handpiece than when the sweat glands themselves aretargeted, exposing the nerve branches 3605 to a cutting tool. The exactdepth of the dissection plane may be selected by the physician based onother considerations of the local anatomy, like vasculature to beavoided, etc. In this approach, subjecting the tissue to adequatetension by the reduced air pressure applied to the recessed area, orinjection of fluid into the dissection plane may assist in achievingadequate separation of the nerve ends to prevent re-growth orre-attachment.

FIG. 36B illustrates an exemplary embodiment of a method according tothe invention, in which a radiofrequency probe 3608 is used to ablate ananatomical area encompassing a sweat gland 3601 and an efferentsympathetic nerve branch 3605. According to methods outlined in FIGS.28B and 28C, and described in more detail in FIGS. 30A-30D, a section ofskin comprising an epidermis 3604 and a dermis 3602 and a subcutaneoustissue 3606 have been moved into a recessed area of a handpiece 3611.The subcutaneous tissue 3606 comprises sweat gland 3601 and efferentsympathetic nerve 3605. A RF ablation probe 3608 has been insertedthrough conduit 3609 into the subcutaneous tissue 3606 comprising thesweat gland 3601 and the nerve 3605. Activation of the RF probe 3608 canbe used to create a heat zone 3610 in the subcutaneous tissue 3606comprising the sweat gland 3601 and the nerve 3605, thereby effectivelythermally ablating the sweat gland 3601 and the nerve 3605.

In alternative embodiments, a handpiece may be a stand-alone tool,capable of applying a reduced air pressure to a skin surface locatedover a previously created subcutaneous lesion, for instance a dissectionplane, during the post-procedural healing period. Periodically applyingreduced air pressure for brief periods of time to an area of skin aftercreating a subcutaneous dissection plane and severing subcutaneousseptae has been shown to have potential benefits on the healingresponse. In particular, a reduction in tissue re-depression aftertreatment of atrophic acne scars has been observed. However, the methodsof use are not limited to this indication, and may be combined with anyof the treatments described in this disclosure. The device and methodsare illustrated in an exemplary embodiment in FIGS. 37A and 37B. Ahandpiece 3700 in FIG. 37A has a top 3701, a perimeter elevation 3702defining a recessed area 3703. The perimeter elevation 3702 is fittedwith a vacuum conduit 3704. The vacuum conduit is configured to beconnected to a vacuum device, for instance a syringe 3706 fitted withlength of tubing 3707. After placing the handpiece 3700 on the surfaceof the skin 3708, reduced air pressure is applied by moving the plungerof the syringe 3706 in the proximal direction 3709, thereby creating avacuum in the recessed area 3703 and drawing the surface of the skin3708 into the recessed area 3703, as shown in FIG. 37B. Alternativelyreduced air pressure may be applied using a vacuum pump or othersuitable source of suction. The reduced air pressure thus applied putstraction 3710 on the pocket 3711 around the subcutaneous plane,potentially improving the local healing response.

In another embodiment the device may be configured as a kit forpost-procedural treatment of a previously created lesion or dissectionplane in a home setting or by a non-physician medical professional,wherein the kit comprises a handpiece, and vacuum device and a means tocouple the handpiece to the vacuum device. Methods of use of theembodiments according to the invention may include in-office proceduresperformed by a healthcare professional, or use as a home therapy, to beapplied by a patient, family member or other non-professionalindividual. The reduced air pressure may be controlled by any of themeans described earlier in this disclosure, including simplemanipulation of a syringe.

In some embodiments, methods to perform minimally invasive subcutaneoussurgery are directed at creating a lesion configured as a subcutaneoustissue pocket and the introduction of a substance by a physician. Thelesion may be specifically configured as a tissue pocket for aparticular substance, such as a solid implant, in which case the pocketmay be shaped according to the shape of the implant. For instance, foran implant requiring subcutaneous tunneling, an elongated tissue pocketmay be created, for a subcutaneous venous access device a circularpocket may be appropriate, and for a shape-correction cosmetic implant acustom-shaped pocket for the implant may be required. In other cases thelesion may be enlarged by the introduction of the implant itself, andthe initial configuration of the pocket may such that it accommodates aleading edge of the implant to facilitate its introduction. In somecases a liquid substance may be introduced, and the lesion needs to beconfigured as a tissue pocket large enough to accommodate the entireinjected volume without the risk of the fluid being expelled through theaccess site by the elasticity of the surrounding tissue.

The substance may comprise a medical device, a drug, a biologic, or acombination device, or any combination of these four categories. Thedefinitions of these categories for the purpose of this disclosure arelisted below. They are generally in line with the definitions as used bythe United States Food and Drug Administration (FDA) as of September2013. Briefly:

-   -   A medical device is a medical product that derives its benefit        from a mechanical action.    -   A drug is a medical product that derives its benefit from a        chemical or biochemical action.    -   A biologic is a medical product that is derived from a natural        source.    -   A combination product is a medical product that combines two or        more regulated medical components.        Additionally, the substance may comprise non-regulated        components, such as pharmacy-compounded compositions. Also, the        substance may comprise autologous tissue harvested from an        alternative site on the anatomy of a patient. Adipose tissue and        segments of bone are examples of materials frequently used as        space-filling implants in corrective cosmetic surgery.

The substances may comprise fluids, semi-solids like injectable gels,and solid implants. Fluids may be actively injected, for instance byusing a syringe, or may be drawn into the pocket from an externalreservoir by reduced pressure applied to a handpiece. Fluids may performa number of functions, including enlarging the subcutaneous tissuepocket, providing structural support, and affecting the biologicalresponse to the procedure by means of a drug. Simple enlargement of thetissue pocket may be achieved by the injection of, for instance, aphysiological saline solution. Support for the pocket and surroundingtissue may be achieved by injection of a fluid containing a liquidpolymer formulation to enhance viscosity, or by injection of asuspension of microparticles.

Suitable polymers for injection include commonly used materials forcosmetic and reconstructive surgery, such as collagen and hyaluronicacid. Suitable microparticulate systems include formulations based onbiodegradable polymers, like poly-lactic acid and poly-glycolic acid andtheir copolymers, poly-caprolactone, poly-urethanes, poly-phosphazenes,poly-anhydrides, poly-orthoesters, polypeptides, poly-saccharides andpolycarbonates. Permanently implanted materials may include silicones,poly-olefins, poly-urethanes, poly-acrylates and poly-methacrylates,poly alkylene oxides, polyols, such as polyvinyl alcohol,poly-vinylpyrrolidones, and poly-fluorinated polymers, such aspoly-tetrafluoroethylene. The materials may comprise linear polymers,crosslinked polymers, homo-polymers and co-polymers.

Drugs may include compounds like local anesthetics, anti-inflammatories,anti-biotics, hemostatics, and healing response modifiers like collagenpromoters. Multiple functions can be combined in an injected fluid, forinstance the polymeric components may be used as controlled releasecarriers for the drugs.

Solid subcutaneous implants may be used for a variety of purposes. Theyinclude shape-enhancing implants used in cosmetic or reconstructivesurgery and therapeutically used implants, like electronic devices anddrug delivery systems.

Cosmetic or reconstructive solid subcutaneous implants are most commonlyused in the face, neck, breast and buttock areas. They typically performa supporting, enlarging or defect-filling function, and can have a widevariety of shapes and consistencies, depending on the specific cosmeticcorrections intended. They may be used in the form of solid implants, inwhich case a relatively large incision may be required for placement, orthey may be of an inflatable design, in which case they may beintroduced through a relatively small incision.

Therapeutically used solid subcutaneous implants include vascular accessdevices like venous infusion ports and subcutaneous hemodialysiscatheters, drug delivery devices, like birth control implants or devicesreleasing chemotherapeutics or hormonal treatments, and a number ofelectronic devices, like subcutaneous defibrillators and pacemakers,battery packs, identity chips, etc. They are preferably implanted inanatomical areas with relatively little mobility, frequently on theupper chest. Smaller drug delivery implants are often implanted on themedial aspect of the upper arm.

Steps comprised in exemplary methods of the invention for creation of adissection plane to form a tissue pocket and placement of a substance inthe tissue pocket are schematically outlined in the flowchart of FIG.28D, and described in more detail in FIGS. 38A-38E. Briefly, as outlinedin FIG. 281), a section of skin and underlying tissue to be treated isanesthetized. Alternatively, general anesthesia may be employed. Next, ahandpiece having a recessed area according to the invention is placedover the section of skin to be treated. Reduced air pressure is appliedto the recessed area of the handpiece, lifting the skin and theunderlying tissue into the recessed area. The depth of the handpiece maybe set at a level that allows the tissue plane to be dissected to alignwith a tool conduit. A lesion creation tool is inserted, and a lesion inthe form of a tissue pocket created, typically by moving the lesioncreation tool along a guidance track. After completion of the lesion thelesion creation tool is removed, and a substance introduction toolinserted. A substance is introduced into the tissue pocket, thesubstance introduction tool removed, the reduced pressure released, andthe handpiece removed.

In some embodiments, the substance to be introduced may comprise afluid, and the substance introduction tool may be a syringe. In someembodiments of the invention, the substance to be introduced maycomprise a solid, and the substance introduction tool may be a probehaving a cavity holding the implant and a push rod to advance theimplant out of the cavity and into the subcutaneous tissue pocket. Insome embodiments the substance introduction tool may serve as atrocar-like conduit to introduce a solid implant. In some embodimentsthe substance introduction tool may be configured to enlarge thesubcutaneous lesion into a larger tissue pocket. In some embodiments ofthe invention a physician may introduce a solid implant manually,without the aid of an introduction tool. In some embodiments of theinvention, the order of steps may be changed. For instance, the reducedair pressure may be released before inserting the substance introductiontool.

FIGS. 38A-38E further illustrate an exemplary method to create asubcutaneous tissue pocket and introduce a solid implant into thepocket. As outlined in the flow chart shown in FIG. 28D, a section ofskin and subcutaneous tissue to be treated is first anesthetized. Next,as further illustrated in FIG. 38A, a handpiece 3801 with a recessedarea, having a vacuum conduit 3802 and a tool conduit 3803 is placed ontop of the epidermis 3804. As illustrated in FIG. 38B, a reduced airpressure is then applied through conduit 3802, pulling the epidermis3804 and the dermis 3805 into the recessed area 3816 of the handpiece3801. A dissection tool 3806 is then inserted through the tool conduit3803 into subcutaneous tissue 3814 underneath the dermis 3805 and adissection plane 3807 is created. In a subsequent step, illustrated inFIG. 38C, a tissue pocket 3808 is created or enlarged by inserting asubstance introduction tool 3809. The substance introduction tool 3809comprises a cavity 3810 and a push rod 3811. The cavity 3810 holds asolid implant 3812. In a next step, illustrated in FIG. 38D, thesubstance introduction tool 3809 is withdrawn in the direction of arrow3813, while holding push rod 3811 stationary, effectively expellingimplant 3812 out of the cavity 3810. The substance introduction tool isremoved, the reduced air pressure released and the handpiece removed. Asshown in FIG. 38E, this allows the epidermis 3804 and the dermis 3805 torelax, and form a subcutaneous tissue pocket 3808 with subcutaneoustissue 3814 around implant 3812.

Although the present invention has been described in detail with regardto the preferred embodiments and drawings thereof, it should be apparentto those of ordinary skill in the art that various adaptations andmodifications of the present invention may be accomplished withoutdeparting from the spirit and the scope of the invention. Accordingly,it is to be understood that the detailed description and theaccompanying drawings as set forth hereinabove are not intended to limitthe breadth of the present invention.

What is claimed:
 1. A minimally invasive skin treatment device,comprising: a handpiece having a perimeter wall and a tissue appositionsurface disposed on the handpiece, wherein the tissue apposition surfaceand perimeter wall forms a recessed area; and a conduit disposed on aside of a perimeter wall, wherein the conduit is configured to allowpassage of a cutting tool through the conduit and into the recessedarea, the conduit being configured to allow the tool to bepercutaneously inserted into a tissue disposed within the recessed areasuch that a distal end of the tool is maintained substantially parallelto a substantial portion of a surface of the tissue.